Events

Device Recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Philips Medical Systems North America Inc. 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
    67612
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1232-2014
  • 사례 시작날짜
    2014-02-06
  • 사례 출판 날짜
    2014-03-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125837
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • 원인
    Philips is recalling heartstart home and onsite (hs1) automated external defibrillators (aeds) because one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed. if poor contact between the pads cartridge and aed occurs, the device may be unable to deliver therapy in an emergency.
  • 조치
    Philips began sending out the Urgent Medical Device Recall HeartStart Home and OnSite (HS1) letter, dated 2014 FEB 10, to consignees on 2/17/14. The letter identified the product, the problem, and the action to be taken by the customer. Customers are advised to contact Philips for a replacement AED at 1-800-263-3342 and select option 5. Live technical support is available Monday through Friday, 7:00AM to 5:00PM PST. Customers can also leave a message 24 hours a day, seven days a week. DISTRIBUTORS are instructed to provide Philips with the information provided in the letter. Customers who have an affected device will be supplied with a replacement AED from Philips, free of charge. If customers/distributors need any further information or support concerning this issue, please visit www.philips.com/HeartStartHS1PinAction.

Device

Device Recall Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs)
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide
  • 제품 설명
    Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). || Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. || Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
  • Manufacturer
    Philips Medical Systems North America Inc.

Manufacturer

Philips Medical Systems North America Inc.
  • 제조사 주소
    Philips Medical Systems North America Inc., 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA