Events

Device Recall BleaseFocus Anesthesia Workstations 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Del Mar Reynolds Medical, Ltd. 에 의해 제조된 제품과 관련되어 있습니다.

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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
    64535
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0968-2013
  • 사례 시작날짜
    2013-01-15
  • 사례 출판 날짜
    2013-03-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-05-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116425
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • 원인
    A defect in cas i/ii absorbers in the spacelabs anesthesia workstations and service kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
  • 조치
    Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter, dated 16 January 2013, to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers until a Spacelabs representative replaces the affected product: 1) Immediately cease the use of BleaseSirius and BleaseFocus Anesthesia Workstations that shipped after 31 October 2012. 2) Immediately cease use of Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from such Service Kit. 3) Advise your staff of this situation Customers can call Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical support.

Device

Device Recall BleaseFocus Anesthesia Workstations
  • 모델명 / 제조번호(시리얼번호)
    serial numbers:  ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087.   Firm added ABSO 004581 - which was inSpacelaabs inventory, in transit to a Field Service Engineer, at the time the recall was initiated. the nonconforming absorber has been replaced with a conforming part and this absober serial number was added to the US Spacelabs Recall tracking.  Five incorrect serialnumbers were included in the original serial numbers provided to FDA. This was a result of a data entry error. An updated US and Rest of the World customer/Serial number was provided to FDA 3/25/2013. The correction to the Rest of the World report is as follows: Incorrect SN Reported to FDA Correct, Nonconforming SN ABSO 005883 ABSO-004514 ABSO 005884 ABSO-004515 ABSO 005885 ABSO-004516 ABSO 005886 ABSO-004517 ABSO 005887 ABSO-004518
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
  • 제품 설명
    Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. || Anesthesia workstation for use in the hospital environment and locations not requiring portability.
  • Manufacturer
    Del Mar Reynolds Medical, Ltd.

Manufacturer

Del Mar Reynolds Medical, Ltd.
  • 제조사 주소
    Del Mar Reynolds Medical, Ltd., 1-2 Harforde Ct., Foxholes, Business Park, Hertford United Kingdom
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA