Events

Philips HeartStart MRx Monitor/Defibrillator with Q-CPR 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-00196-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00196-1
  • 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
    When the heartstart mrx is in aed mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon during the shock advisory analysis period. if the user continues to deliver chest compressions when the shock advisory analysis begins, the ‘do not touch the patient’ icon may incorrectly remain on the screen after analysis or shock delivery is complete.When the heartstart mrx is in manual mode, the q-cpr meter is designed to display the ‘do not touch the patient’ icon when the device is charging to the selected energy. if the clinician continues to provide chest compressions while the device is charging, the q-cpr meter ‘do not touch the patient” icon may incorrectly remain on the screen after shock delivery is complete.Due to incorrect cpr instructions, the clinician may follow the 'do not touch the patient command on the q-cpr meter and may not resume chest compressions in a timely manner resulting in a delay in the delivery of cpr.
  • 조치
    A software upgrade will be provided to customers with affected devices. Customers are advised to use their HeartStart MRx without the Q-CPR meter attached. If customers choose to use the HeartStart MRx with the Q-CPR meter attached and they observe that the Q-CPR meter is displaying the 'Do Not Touch The Patient' icon at an unexpected time, follow the MRx Instructions For Use and remove the eter from the patient and continue CPR according to their organization's protocol.

Device

Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
  • 모델명 / 제조번호(시리얼번호)
    Philips HeartStart MRx Monitor/Defibrillator with Q-CPRUnits Affected: MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587ARTG Number: 95661
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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