Events

Portable patient monitor with arrhythmia detection or alarms. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Spacelabs Healthcare, Llc 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
    56806
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3036-2011
  • 사례 시작날짜
    2010-09-17
  • 사례 출판 날짜
    2011-08-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-08-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94553
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • 원인
    Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. cause is a software problem.
  • 조치
    Spacelabs Medical sent an "URGENT - MEDICAL DEVICE CORRECTION" notification letter to U.S. consignees by mail on September 17, 2010 and to international consignees by e-mail on September 24, 2010. The letter identified the recalled product, warns customers of the potential hazard and identifies some ways to mitigate the risk if they decide to continue use. The letter states to correct this situation, the recalling firm Field Service Engineers will be contact customers to schedule a time to install a free software update. If customers have any questions about this corrective action program, please contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.

Device

Portable patient monitor with arrhythmia detection or alarms.
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS: 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 1367-000112, 1367-000113, 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  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.
  • 제품 설명
    Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. || Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • 제조사 주소
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • 제조사 모회사 (2017)
    OSI Systems Inc
  • Source
    USFDA