Events

HeartStart XL+ Defibrillator/Monitor 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Philips Medical Systems 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2014-04-09
  • 사례 출판 날짜
    2014-04-09
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140409.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: philips heartstart xl+ defibrillator/monitor medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning its heartstart xl+ defibrillator/monitor (model no.: 861290). the affected serial number ranges are shown below: uso1100106 to uso1100372 usn1100376 to usn1100960 usd1100961 to usd1101095 us11201096 to us11201186 us21201187 to us21201239 us31201240 to us31201537 us41201538 to us41201585 us51201586 to us51201721 us61201722 to us61201924 us71201925 to us71202048 us81202049 to us81202168 us91202169 to us91202514 uso1202515 to uso1202990 usn1202991 to usn1203537 usd1203538 to usd1203968 us11303969 to us11303972 us21303980 to us21304488 us31304489 to us31305042 us41305043 to us41305295 us51305296 to us51305450 us61305451 to us61306138 us71306139 to us71306542 us81306543 to us81306998 us91306999 to us91307261 uso1307306 to uso1307458 usn1307616 to usn1308423 usd1308424 to usd1309471 us11409472 to us11410212 us21410213 to us21410563 according to the manufacturer, a software communication failure on the heartstart xl+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy. the manufacturer is providing a software upgrade to users with affected devices. the manufacturer advises affected users to take the following actions:- while awaiting the software upgrade, users may continue to use the heartstart xl+ unless the device exhibits a red x, presents an audio chirp and displays the user message: “equipment disabled: therapy”. this is an indicator that the device self-test has detected the problem and is not ready for use. in the case the problem cannot be resolved by running op-check, users should identify a readily available backup defibrillator to use in the event the affected heartstart xl+ exhibits the communication failure. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 april 2014.

Device

HeartStart XL+ Defibrillator/Monitor
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: [6 Jul 2015] Philips Medical Systems HeartStart XL+ Defibrillator/Monitor
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • 제조사 모회사 (2017)
    Philips
  • Source
    DH