Events

SCHILLER FRED AED: Defibrillation Electrodes 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Schiller 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 ID
    MDA/2012/043
  • 사례 연번
    CON172294
  • 날짜
    2012-07-11
  • 사례 출판 날짜
    2012-07-11
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON172294?tabName=allTabs
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • 데이터 추가 비고
  • 원인
    Premature drying up of electrodes due to a manufacturing quality problem. this may prevent shock delivery, which may result in failure to defibrillate and a reduced chance of survival for the patient. users have reported that these electrodes partially dry up before their expiry date, possibly due to variations in the manufacturing process. if the electrodes partially dry up, there is a risk that they will not be detected by the defibrillator, as their impedance is too high.
  • 조치
    See manufacturer’s Field Safety Notice issued May 2012 by Amazon Medical Limited. MDA/2012/042 and MDA/2012/043 refer to this Field Safety Notice. Check inventory and identify affected electrodes. If affected, immediately contact Amazon Medical Limited for replacement electrodes. Return the fax back confirmation form in the FSN to Amazon Medical Limited.

Device

SCHILLER FRED AED: Defibrillation Electrodes
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Schiller electrodes: silver packet, manufactured by Nessler Medizintechnik. All (Paediatric and Adult) devices are affected. Devices are distributed by Amazon Medical Ltd. The electrodes (example, right) are supplied with the FRED defibrillators or can be acquired as an accessory. All those electrodes produced before January 2011 are affected. SCHILLER FRED AED: Defibrillation Electrodes - Nessler Medizintechnik Product Article number FRED defibrillation electrodes Adult REF W1410241 FRED defibrillation electrodes Child Same packet – labelled Child REF W1410262 Schiller Fred easyport, APLC1 & APLC2 Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easyport defibrillation electrodes - Adult Same size packet as 2.155057 REF 2.155056 FRED easyport defibrillation electrodes - Child REF 2.155057 APLC1 & APLC2 defibrillation electrodes Adult REF 0‐21‐0024 Schiller Fred easy Defibrillation Electrodes – Nessler Medizintechnik Product Article number FRED easy defibrillation electrodes REF 0-21-0003 FRED easy REF 0-21-0020 FRED easy REF 0-21-0000 FRED easy REF 0-21-0021 The Schiller electrodes are used with the following defibrillators/monitors manufactured by Schiller. Products FRED easy Basic FRED easy ECG on-screen FRED easy Manual FRED AED FRED easyport APLC1 FRED easyport APLC2 AT101 easy Argus Pro Lifecare 1 Argus Pro Lifecare 2
  • Manufacturer
    Schiller

Manufacturer

Schiller