Events

Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia Ltd 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-00629-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-05-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00629-1
  • 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
    Investigations conducted by philips subsequent to customer complaints have revealed that a small number of intellivue neuromuscular transmission (nmt) patient cables may contain a localised isolation defect in the shielding of the acceleration sensor housing. this manufacturing defect may cause localised heating due to an unintended current flow between the acceleration sensor housing attached to the patient thumb and the nmt stimulation electrode connection attached to the wrist of the same hand. using a defective nmt patient cable on a patient under anaesthesia who receives repeated nmt stimulations during a procedure may result in a localised skin burn of up to several millimetres in diameter.
  • 조치
    Philips is requesting customers to identify all affected cables by checking their inventory for NMT patient cables that bear the CE mark with the suffix "0366". The affected stock is to be removed from inventory and quarantined. Customers will be contacted by a Philips Healthcare representative or an authorised service provider to arrange for a visit to replace the affected cables.

Device

Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue ...
  • 모델명 / 제조번호(시리얼번호)
    Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors)Philips IntelliVue NMT Patient CablesModel: 989803174581Cable also supplied in Philips IntelliVue NMT Module, Product Option #K01, Model : 865383 #K01 Cables that have CE Mark with suffix 0366 ARTG Number: 202378
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA