Events

Device Recall Physio Control LIFEPAK 1000 Defibrillator 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Physio-Control, 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
    67963
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1660-2014
  • 사례 시작날짜
    2014-05-09
  • 사례 출판 날짜
    2014-05-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126669
  • 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
    Physio-control has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. a software malfunction in the lifepak 100.
  • 조치
    On May 9, 2014 Physio-Control sent an Urgent Medical Device Recall Letter (dated May 2014) to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customer notification letter will provide new instructions on how to check the functional and power readiness of the device and advise the customer on the actions to take based on the symbol displayed. Customers are asked to record the readiness indicator(s) shown on each device and fax the confirmation sheet back to Physio-Control at 1-866-448-9567. Customers are also directed to contact Physio-Control at 1-800-442-1142 to obtain replacement batteries, if needed. Customers are provided a Device Readiness Guide for use in interpreting the Readiness Display on the device, and are directed to refer to the Operating Instructions which were provided upon purchase. In addition to notifying Physio-Control of any potential quality problems or adverse reactions or events experienced associated to the use of these products, Physio-Control asks customers to report directly to the FDA through the MedWatch Adverse Reporting Program online, by regular mail or by fax. Physio-Control reminds customers that it is critically important in understanding what the device and battery indicators mean on your defibrillator and what actions you need to take as a result. At any time the battery charge can be verified by following the instruction provided on page 2-5 of the Operating Instructions. It is also important that you always carry a spare fully-charged battery, as stated in the Operating Instructions. Customers are directed to call Physio-Control at 1-800-442-1142, 6:00 a.m. to 4:00p.m. (Pacific), Monday - Friday for any further questions. ********************************************************************************************* On May 18, 2015, Physio Control sent the Urgent Medical Correction-Action Required LIFEPAK 1000 DEFIBRILLATOR to U

Device

Device Recall Physio Control LIFEPAK 1000 Defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA AND HERZOGOVENIA, BRAZIL, BRUNEI DARUSSALAM, CANADA, CANARY ISLANDS, CAYMAN ISLANDS, CHILE, China, COLOMBIA, COSTA RICA, CROATIA, Curacao, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, Espa¿a, FAROE ISLANDS, FINLAND, FRANCE, FRENCH GUIANA, FRENCH POLYNESIA, GABON, GEORGIA, GERMANY, GREECE, GUAM, GUATEMALA, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF, IRAQ, IRELAND, ISRAEL, ITALY, Japan, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, MACAU, MACEDONIA, THE FORMER YUGOSL, MALAYSIA, MALDIVES, MALTA, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA FEDERATION, SAN MARINO, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, Suriname, South America, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, TURKMENISTAN, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
  • 제품 설명
    LIFEPAK 1000 defibrillator. Affected Part Numbers: 320371500XXX || The LP1000 (in AED mode) is indicated for use on patients in cardiac arrest.
  • Manufacturer
    Physio-Control, Inc.

Manufacturer

Physio-Control, Inc.
  • 제조사 주소
    Physio-Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA