Device Recall Spacelabs Medical Patient Monitor

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers:  1367-000023, 1367-000234, 1367-000237, 1367-000238, 1367-000272, 1367-000279, 1367-000280, 1367-000281, 1367-000282, 1367-000283, 1367-000284, 1367-000361, 1367-000368, 1367-000369, 1367-000694, 1367-000695, 1367-000696, 1367-000697, 1367-000698, 1367-000699, 1367-000700, 1367-000701, 1367-000702, 1367-000703, 1367-000704, 1367-000705, 1367-000706, 1367-000707, 1367-000708, 1367-000709, 1367-000710, 1367-000711, 1367-001052, 1367-001198, 1367-001344, 1369-001517, 1369-003041, 1369-003077, 1369-003141, 1369-003215, 1369-003596, 1369-003598, 1369-004170, 1369-004217, 1369-004247, 1369-004868, 1369-005316, 1369-005334, 1369-005561, 1369-005562, 1369-005676, 1369-005744, 1369-005745, 1369-005746, 1369-005911, 1369-005912, 1369-005913, 1369-005914, 1369-005918, 1369-005919, 1369-005920, 1369-005921, 1369-006100, 1369-006132, 1369-006143, 1369-006223, 1369-006224, 1369-006281, 1369-006365, 1369-006366, 1369-006380, 1369-006641, 1369-006643, 1369-006829, 1369-006860, 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1387-102612, 1387-102616, 1387-102812, 1387-102813, 1387-102953, 1387-103011, 1387-103035, 1387-103182, 1387-103183, 1387-103202, 1387-103310, 1387-103341, 1387-103342, 1387-103343, 1387-103344, 1387-103345, 1387-103346, 1387-103347, 1387-103348, 1387-103349, 1387-103350, 1387-103351, 1387-103357, 1387-103358, 1387-103359, 1387-103360, 1387-103361, 1387-103362, 1387-103438, 1387-103439, 1387-103457, 1387-103458, 1387-103459, 1387-103460, 1387-103461, 1387-103462, 1387-103463, 1387-103464, 1387-103465, 1387-103466, 1387-103518, 1387-103535, 1387-103536, 1387-103537, 1387-103538, 1387-103539, 1387-103540, 1387-103541, 1387-103542, 1387-103543, 1387-103544, 1387-103545, 1387-103546, 1387-103547, 1387-103548, 1387-103549, 1387-103550, 1387-103551, 1387-103604, 1387-103605, 1387-103606, 1387-103607, 1387-103608, 1387-103609, 1387-103659, 1387-103660, 1387-103661, 1387-103662, 1387-103663, 1387-103664, 1387-103665, 1387-103666, 1387-103749, 1387-103797, 1387-103798, 1387-103799, 1387-103800, 1387-103801, 1387-103802, 1387-103803, 1387-103815, 1387-103816, 1387-103823, 1387-103824, 1387-103825, 1387-103826, 1387-103827, 1387-103828, 1387-103829, 1387-103830, 1387-103831, 1387-103832, 1387-103833, 1387-103834, 1387-103835, 1387-103836, 1387-103837, 1387-103838, 1387-103839, 1387-103840, 1387-103841, 1387-103842, 1387-103843, 1387-103844, 1387-103846, 1387-103847, 1387-103848, 1387-103849, 1387-103850, 1387-103851, 1387-103852, 1387-103853, 1387-103854, 1387-103855, 1387-103856, 1387-103857, 1387-103884, 1387-103885, 1387-103886, 1387-103887, 1387-103888, 1387-104021, 1387-104022, 1387-104023, 1387-104024, 1387-104106, 1387-104223, 1387-104308, 1387-104309, 1387-104310, 1387-104311, 1387-104312, 1387-104313, 1387-104392, 1387-104393, 1387-104394, 1387-104395, 1387-104396, 1387-104397, 1387-104398, 1387-104399, 1387-104400, 1387-104403, 1387-104404, 1387-104405, 1387-104406, 1387-104407, 1387-104428, 1387-104462, 1387-104579, 1387-104580, 1387-104587, 1387-104590, 1387-104672, 1387-104697, 1387-104727, 1387-104728, 1387-104729, 1387-104730, 1387-104731, 1387-104732, 1387-104733, 1387-104734, 1387-104735, 1387-104736, 1387-104742, 1387-104760, 1387-104761, 1387-104850, 1387-104851, 1387-104852, 1387-104853, 1387-104883, 1387-104885, 1387-104905, 1387-104908, 1387-104952, 1387-104953, 1387-104977, 1387-104978, 1387-105013, 1387-105019, 1387-105028, 1387-105032, 1387-105093, 1387-105094, 1387-105095, 1387-105096, 1387-105098, 1387-105117, 1387-105118, 1387-105120, 1387-105134, 1387-105135, 1387-105137, 1387-105276, 1387-105342, 1387-105343, 1387-105466, 1387-105467, 1387-105468, 1387-105469, 1387-105478, 1387-105479, 1387-105480, 1387-105681, 1387-105682, 1387-105683, 1387-105684, 1387-105687, 1387-105696, 1387-105697, 1387-105698, 1387-105699, 1387-105700, 1387-105701, 1387-105702, 1387-105703, 1387-105704, 1387-105727, 1387-105728, 1393-000013, 1393-000039, 1393-000040, 1393-000041, 1393-000062, 1393-000063, 1393-000064, 1393-000065, 1393-000066, 1393-000067, 1393-000068, 1393-000069, 1393-000070, 1393-000071, 1393-000096, 1393-000097, 1393-000113, 1393-000114, 1393-000115, 1393-000116, 1393-000117, 1393-000118, 1393-000119, 1393-000120, 1393-000121, 1393-000122, 1393-000123, 1393-000124, 1393-000125, 1393-000126, 1393-000127, 1393-000128, 1393-000129, 1393-000130, 1393-000228, 1393-000229, 1393-000382, 1393-000383, 1393-000384, 1393-000385, 1393-000386, 1393-000387, 1393-000388, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000548, 1393-000549, 1393-000550, 1393-000620, 1393-000621, 1393-000774, 1393-000775, 1393-000776, 1393-000777, 1393-000778, 1393-000779, 1393-000780, 1393-000782, 1393-000808, 1393-000809, 1393-00235, 1393-00236, 1393-00237, 1393-00238,  1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346,  1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351,  1393-00352, 1393-00353, 1393-00354, and 1393-00355.   Additional serial numbers provided on 9/22/11: D5129719, S5116918, S5129089, S5132098, S5132108, S5132142, S5132754, S5134828, S5135370, S5139030, S5139569, S5142218, S5144443, S5154715, S5156840, S5157705, S5159595, S5164214, S5174050, S5185302, S5188765, S5348911, S5354947, S5368108, S5373811, and S5418867.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Australia, Bahrain, Bolivia, Brazil, Canada, Caymen Island, Chile, China, Colombia, Cyprus, Ecuador, Finland, France, Germany, Guam, India, Indonesia, Israel, Italy, Jordan, Mexico, Morocco, New Zealand, Nicaragua, Pakistan, Paraguay, Peru, Philippines, Poland, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, Uruguay, and Venezuela.
  • 제품 설명
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, & 91393 are sold with with Perioperative Mode (option D), which includes Start case/End case functionality. || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. || Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. || Product Usage: When a clinician enters END CASE mode, there is the expectation the operation is over and the patient is being disconnected from the monitor. Removing the patient cables will trigger multiple alarms so clinicians will enter this END CASE mode to prevent having to listen to false alarms. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine: a) when an alarm condition is violated; b) the alarm priority (ie. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open Windows and display information on other net worked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

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  • 모델명 / 제조번호(시리얼번호)
    The same KIT PART Number (PN 040-1458-00) identified on 12 units distributed IN the US and on 3 units distributed OUTSIDE of the US. These 15 units will receive serial numbers after the software upgrade is installed.   THERE ARE 70 SERIAL NUMBERS ON UNITS DISTRIBUTED IN THE US:  040-1548-00, 1367-000033, 1369-001517, 1369-003051, 1369-003077, 1369-004247, 1369-005914, 1369-006877, 1369-007165, 1369-008519, 1369-010292, 1369-011637, 1369-017520, 1369-061217, 1370-000013, 1370-000014, 1370-000025, 1370-000095, 1370-000285, 1370-000449, 1370-000471, 1370-000579, 1370-000658, 1370-001700, 1370-002494, 1370-002510, 1370-003785, 1370-004176, 1370-004184, 1370-004275, 1370-004292, 1387-000465, 1387-000535, 1387-000543, 1387-001071, 1387-001677, 1387-006200, 1387-010824, 1387-010830, 1387-011914, 1387-014142, 1387-014159, 1387-014184, 1387-014186, 1387-014187, 1387-014188, 1387-014596, 1387-015721, 1387-015722, 1387-015723, 1387-016045, 1387-018424, 1387-018947, 1387-019766, 1387-019768, 1387-019769, 1387-019771, 1387-019772, 1387-100036, 1387-101646, 1387-104672, 1387-105801, 1387-105811, 1387-105812, 1387-105882, 1393-000442, 1393-000579, 1393-000580, 1393-000581, 1393-000582, and 387-002421.   THERE ARE 137 SERIAL NUMBERS IDENTIFIED ON UNITS DISTRIBUTED OUTSIDE OF THE US:  1369-000011, 1369-000165, 1369-000407, 1369-000928, 1369-002976, 1369-003388, 1369-005316, 1369-005334, 1369-006100, 1369-006281, 1369-007338, 1369-009142, 1369-009143, 1369-009144, 1369-009145, 1369-009146, 1369-009889, 1369-009890, 1369-011741, 1369-011742, 1369-011743, 1369-011744, 1369-011745, 1369-013721, 1369-016648, 1369-016649, 1369-017759, 1369-017791, 1369-017792, 1370-000026, 1370-000725, 1370-000771, 1370-002373, 1370-002378, 1370-002380, 1370-002381, 1370-002382, 1370-002383, 1370-002384, 1370-003809, 1370-004133, 1370-004277, 1370-004509, 1370-004510, 1370-004511, 1370-004516, 1370-004617, 1370-200366, 1370-200370, 1370-200374, 1370-200375, 1370-200376, 1370-200378, 1370-200380, 1370-200471, 1370-200473, 1370-200474, 1370-200475, 1370-200476, 1370-200691, 1387-000044, 1387-000447, 1387-000467, 1387-000548, 1387-001086, 1387-002157, 1387-005006, 1387-008003, 1387-008310, 1387-010742, 1387-013241, 1387-013716, 1387-014610, 1387-018104, 1387-018105, 1387-018171, 1387-018176, 1387-018277, 1387-018638, 1387-018817, 1387-019563, 1387-100148, 1387-100150, 1387-100151, 1387-100155, 1387-100906, 1387-101061, 1387-101062, 1387-101063, 1387-101064, 1387-101065, 1387-101066, 1387-101067, 1387-102222, 1387-103550, 1387-103659, 1387-104462, 1387-105831, 1387-105832, 1387-105833, 1387-105834, 1393-000013, 1393-000517, 1393-000518, 1393-000519, 1393-000520, 1393-000521, 1393-000522, 1393-000523, 1393-000524, 1393-000525, 1393-000808, 1393-000809, 1393-000822, 1393-000831, 1393-000833, 1393-000834, 1393-000851, 1393-000852, 1393-00235, 1393-00236, 1393-00237, 1393-00238, 1393-00239, 1393-00240, 1393-00241, 1393-00335, 1393-00346, 1393-00347, 1393-00348, 1393-00349, 1393-00350, 1393-00351, 1393-00352, 1393-00353, 1393-00354, AND 1393-00355.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution- US (nationwide) including the states of: FL, GA, IA, KY, LA, MA, MI, MN, MO, MS, NJ, NY, OH, OK, PA, SC, TN, TX, WA, Guam and Puerto Rico and to the following countries: Argentina, Australia, Canada, China, Czech Republic, Finland, France, Germany, Greece, India, Israel, Italy, Netherlands, New Zealand, Panama, Paraguay, Poland, Singapore, Spain, Sri Lanka, Switzerland, Tunisia, United Kingdom, and Uruguay.
  • 제품 설명
    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. || Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. || Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed
  • Manufacturer