Events

Philips HeartStart MRx Monitor/Defibrillator 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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
    RC-2014-RN-00187-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00187-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    A component of the mrx processor board may be susceptible to damage from electrostatic discharge (esd). damage to these components can disrupt ecg and spo2 functionality leading to an inability to perform:- demand mode pacing- 12 lead ecg acquisition and analysis- ecg monitoring via leads- pulse oximetry (spo2)the presence of this condition will be displayed on the ready for use (rfu) indicator as a solid red x with periodic audio chirp.
  • 조치
    A hardware upgrade will be provided to correct the issue. Philips is advising healthcare professionals that the MRx can continue to be used prior to receiving the hardware update. Philips is also advising users to immediately contact their Philips authorised service personnel if it is observed that the MRx is displaying a solid red ‘X’ in the RFU indicator and displaying the 'ECG Equip Malfunction' INOP, a failure that may disable some ECG and SpO2 functionality.

Device

Philips HeartStart MRx Monitor/Defibrillator
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx Monitor/DefibrillatorModel numbers M3535A, M3536A, M3536J, M3536MCSerial numbers within the following ranges:Model M3535A: US00100100 to US00541372Model M3536A: US00100902 to US00541375Model M3536J: US00209838 to US00332675Model M3536MC: US00500001 to US00500020 ARTG Number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA