Events

Device Recall Welch Allyn PIC 50 Portable Monitor/Defibrillator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 MRL, Inc., A Welch Allyn Company 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
    36785
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0343-2007
  • 사례 시작날짜
    2006-11-15
  • 사례 출판 날짜
    2007-01-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-10-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49357
  • 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
    Defibrillator - Product Code MJK
  • 원인
    Shock delay:the monitor-defibrillator may display an 'ecg comm' error message on the display during use, which may prevent or cause an unacceptable delay the delivery of a defibrillation shock. this delay could result in failure to resuscitate the patient.
  • 조치
    MRL sent Urgent Medical Device Recall letters dated 11/8/06 via certified mail on 11/15/06 to the direct accounts informing them of an intermittent connection between the J5 cable and its mating connector on a circuit board inside of the device that could result in a malfunction that could prevent or unacceptably delay the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units'' parts/serial numbers and were requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. Until their PIC 50 is serviced, the accounts were instructed to check the unit before each shift by using the self-test, which is automatically initiated by powering up the device. If the 'ECG Comm' error occurs during use, cycling the power off-on may clear the error. Even if power cycling clears the device, the accounts were instructed to contact Welch Allyn - MRL to obtain priority servicing of the affected unit. The accounts were also instructed to respond to the notification within 30 days by fax or mail, or by calling Welch Allyn - MRL Technical Support at 1-800-462-0777, to schedule their PIC 50 for preventative service. Welch Allyn will provide the accounts with a loaner PIC 50 after receiving the form with instructions to send back the PIC 50 in the same shipping box accompanying the loaner unit. Any questions were directed to Welch Allyn-MRL Technical Support at 1-800-462-0777.

Device

Device Recall Welch Allyn PIC 50 Portable Monitor/Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers 971081, 971082, 971083 and 971084; Serial numbers 80052, 80141, 80190, 80191, 80425, 80426, 80430, 80431, 80432, 80435, 80436, 80587, 80826, 80915, 80916, 80918, 80920, 80921, 80923, 80924, 80925, 80926, 80927, 80928, 80929, 80930, 80932, 80934, 80960, 80962, 80963, 80967, 80969, 80971, 80972, 80973, 80974, 80975, 80976, 80981, 80983, 80987, 80989, 80990, 80991, 80992, 80993, 81003, 81004, 81005, 81006, 81007, 81008, 81009, 81010, 81011, 81012, 81013, 81014, 81015, 81016, 81017, 81018, 81019, 81020, 81022, 81023, 81024, 81025, 81026, 81027, 81028, 81029, 81030, 81031, 81032, 81033, 81034, 81035, 81036, 81037, 81038, 81044, 81045, 81046, 81047, 81049, 81070, 81094, 81102, 81103, 81104, 81105, 81109, 81110, 81111, 81112, 81113, 81165, 81167, 81178, 81179, 81181, 81184, 81187, 81188, 81192, 81194, 81197, 81258, 81297, 81499, 81627, 81765, 81767, 81769, 81770, 81773, 81803, 81804, 81823, 81827, 81828, 81829, 81832, 81833, 81834, 81835, 81837, 81838, 81839, 81840, 81841, 81842, 81843, 81844, 81845, 81846, 81853, 81855, 81857, 81858, 81860, 81861, 81862, 81863, 81864, 81865, 81866, 81867, 81868, 81869, 81884, 81885, 81886, 81920, 81921, 81922, 81923, 81924, 81925, 81926, 81927, 81928, 81929, 81930, 81931, 81932, 81933, 81934, 81935, 81936, 81937, 81938, 81939, 81940, 81941, 81942, 81943, 81944, 81945, 81946, 81949, 81957, 81983, 81984, 81985, 81986, 81987, 81988, 81989, 81990, 81996, 81997, 81998, 81999, 82000, 82001, 82003, 82004, 82005, 82016, 82017, 82019, 82021, 82022, 82023, 82024, 82025, 82027, 82028, 82034, 82035, 82036, 82037, 82038, 82039, 82043, 82061, 82062, 82063, 82064, 82065, 82066, 82067, 82068, 82069, 82070, 82071, 82072, 82073, 82074, 82075, 82076, 82077, 82078, 82079, 82080, 82098, 82099, 82100, 82101, 82102, 82103, 82104, 82105, 82106, 82107, 82108, 82109, 82111, 82122, 82123, 82124, 82126, 82127, 82128, 82160, 82161, 82162, 82163, 82164, 82165, 82169, 82172, 82173, 82174, 82175, 82176, 82177, 82178, 82179, 82180, 82181, 82182, 82183, 82184, 82185, 82186, 82192, 82193, 82194, 82195, 82196, 82198, 82199, 82200, 82201, 82202, 82204, 82252, 82253, 82254, 82255, 82256, 82257, 82258, 82259, 82260, 82261, 82262, 82263, 82264, 82265, 82266, 82267, 82268, 82270, 82271, 82272, 82273, 82284, 82285, 82286, 82317, 82318, 82319, 82321, 82322, 82323, 82324, 82325, 82326, 82327, 82328, 82329, 82330, 82342, 82343, 82344, 82346, 82347, 82348, 82349, 82408, 82409, 82411, 82412, 82413, 82414, 82415, 82416, 82417, 82418, 82419, 82421, 82424, 82426, 82430, 82461, 82462, 82463, 82464, 82465, 82466, 82467, 82468, 82469, 82470, 82471, 82472, 82473, 82474, 82475, 82517, 82518, 82519, 82520, 82521, 82522, 82528, 82529, 82530, 82531, 82532, 82533, 82536, 82537, 82538, 82550, 82552, 82553, 82555, 82556, 82557, 82559, 82560, 82561, 82562, 82563, 82564, 82565, 82569, 82570, 82612, 82613, 82614, 82615, 82616, 82617, 82618, 82619, 82621, 82623, 82624, 82625, 82626, 82627, 82628, 82629, 82630, 82631, 82655, 82656, 82657, 82658, 82659, 82660, 82661, 82662, 82663, 82664, 82665, 82666, 82667, 82668, 82669, 82670, 82671, 82672, 82689, 82690, 82773, 82774, 82775, 82776, 82777, 82778, 82779, 82780, 82781, 82782, 82783, 82784, 82785, 82786, 82787, 82788, 82789, 82790, 82791, 82792, 82793, 82794, 82795, 82796, 82797, 82798, 82799, 82800, 82801, 82802, 82803, 82804, 82805, 82806, 82807, 82808, 82809, 82810, 82811, 82812, 82813, 82827, 82828, 82829, 82830, 82852, 82857, 82858, 82859, 82962, 82965, 82966, 82967, 82975, 82986, 82989, 82991, 82998, 83010, 83011, 83012, 83013, 83060, 83061, 83062, 83063, 83064, 83065, 83066, 83067, 83084, 83088, 83089, 83090, 83142, 83144, 83145, 83147
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide-USA, Australia, Belgium, Canada, Egypt, Finland, France, Germany, Ireland, Italy, Jordan, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sultanate of Oman, United Arab Emirates and the United Kingdom.
  • 제품 설명
    Welch Allyn PIC 50 Portable Intensive Care System, Multi-Parameter Monitor/Defibrillator; a portable 12V internal battery powered defibrillator; Manufactured by MRL Inc., a WelchAllyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089-Part Numbers-971081,971082,971083,971084.
  • Manufacturer
    MRL, Inc., A Welch Allyn Company

Manufacturer

MRL, Inc., A Welch Allyn Company
  • 제조사 주소
    MRL, Inc., A Welch Allyn Company, 1000 Asbury Dr Ste 17, Buffalo Grove IL 60089-4551
  • Source
    USFDA