Events

ProBP 2400 Digital Blood Pressure DeviceSerial 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Welch Allyn Australia Pty Limited 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
    RC-2017-RN-00922-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00922-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Welch allyn has been made aware of a product quality issue which could potentially affect the probp 2400 digital blood pressure devices manufactured by microlife and distributed by welch allyn. as a result of a defective electrical component in the battery charging circuit, when the probp 2400 is connected to the external power supply/battery charger, a potential over-voltage battery charging condition may occur. this potential defect resides with the device, not the battery.The over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic (abs) battery door and other adjacent plastic and foam device components.This issue may lead to patient and/or caregiver burns as result of skin contact with melted plastic and/or delays in treatment.
  • 조치
    The affected devices within the Serial Numbers specified in the customer letter are being recalled and will be replaced with new devices at no cost to affected customers.

Device

ProBP 2400 Digital Blood Pressure DeviceSerial
  • 모델명 / 제조번호(시리얼번호)
    ProBP 2400 Digital Blood Pressure DeviceSerial Number ranges:(21)07150001 – (21)07150620 (21)12150001 – (21)12150500 Please note: (21) is NOT part of the Serial Number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the Serial Number on any GUDI compliant label.ARTG Number: 232592
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited