Events

Device Recall Spacelabs Medical Patient Monitor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Llc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    59456
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3032-2011
  • 사례 시작날짜
    2011-07-08
  • 사례 출판 날짜
    2011-08-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102834
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    The clinician did not realize the monitor was in end case mode and was expecting audible alarms. visual alarms continue to work normally.
  • 조치
    Spacelabs sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated July 25, 2011 along with the Perioperative section of the Operations Manual to all consignees in the US. This letter includes recalled model 91369, 91370, 91387, & 91393 (option D). On July 27, 2011, Spacelabs sent out an updated recall notification letter to include one additional model 91367 to all consignees in the US. The letter identifies the products, problem, and actions to be taken. On August 2, 2011, a recall notification letter (translated as necessary) and the Perioperative section of the Operations Manual was emailed to all international subsidiaries and distributors of record. The notification letter stated that the Operating Room staff may not be aware that alarm tones are off if the device has been left in the END CASE state. If the customers make use of the Perioperative START CASE / END CASE feature, they should advise the clinicians to familiarize themselves with this feature as described in the Perioperative section of the Operations Manual. In particular, they should know how to confirm the state of the alarm tones prior to starting a case. The letter states that the firm is in the process of upgrading the software and will be contacting customers to update monitors at no cost. If customers have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.

Device

Device Recall Spacelabs Medical Patient Monitor
  • 모델명 / 제조번호(시리얼번호)
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1387-100298, 1387-100306, 1387-100319, 1387-100514, 1387-100517, 1387-100610, 1387-100611, 1387-100675, 1387-100895, 1387-100896, 1387-100903, 1387-100904, 1387-100905, 1387-100906, 1387-100913, 1387-100914, 1387-100953, 1387-100980, 1387-100981, 1387-100994, 1387-101036, 1387-101043, 1387-101044, 1387-101045, 1387-101046, 1387-101047, 1387-101048, 1387-101050, 1387-101055, 1387-101114, 1387-101115, 1387-101123, 1387-101208, 1387-101222, 1387-101223, 1387-101224, 1387-101233, 1387-101234, 1387-101235, 1387-101236, 1387-101237, 1387-101255, 1387-101273, 1387-101274, 1387-101307, 1387-101350, 1387-101351, 1387-101352, 1387-101353, 1387-101354, 1387-101355, 1387-101356, 1387-101357, 1387-101358, 1387-101359, 1387-101360, 1387-101361, 1387-101362, 1387-101363, 1387-101364, 1387-101365, 1387-101366, 1387-101367, 1387-101368, 1387-101369, 1387-101370, 1387-101371, 1387-101372, 1387-101373, 1387-101374, 1387-101395, 1387-101396, 1387-101397, 1387-101398, 1387-101399, 1387-101400, 1387-101408, 1387-101409, 1387-101410, 1387-101418, 1387-101419, 1387-101701, 1387-101702, 1387-101703, 1387-101704, 1387-101705, 1387-101706, 1387-101727, 1387-101728, 1387-101729, 1387-101852, 1387-101853, 1387-101854, 1387-102044, 1387-102092, 1387-102093, 1387-102094, 1387-102095, 1387-102096, 1387-102097, 1387-102098, 1387-102099, 1387-102100, 1387-102101, 1387-102102, 1387-102104, 1387-102105, 1387-102106, 1387-102107, 1387-102108, 1387-102135, 1387-102136, 1387-102137, 1387-102138, 1387-102139, 1387-102140, 1387-102141, 1387-102142, 1387-102143, 1387-102144, 1387-102145, 1387-102146, 1387-102159, 1387-102162, 1387-102197, 1387-102198, 1387-102221, 1387-102222, 1387-102442, 1387-102443, 1387-102444, 1387-102498, 1387-102499, 1387-102514, 1387-102515, 1387-102533, 1387-102540, 1387-102541, 1387-102542, 1387-102549, 1387-102550, 1387-102551, 1387-102552, 1387-102553, 1387-102601, 1387-102602, 1387-102603, 1387-102604, 1387-102605, 1387-102606, 1387-102608, 1387-102609, 1387-102610, 1387-102611, 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
    Cardiovascular Devices
  • 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
    Spacelabs Healthcare, Llc

Manufacturer

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