Events

Recall of BiPAP A 40 Ventilatory Support System; Detachable Battery Module, USA/INTL

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01438-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01438-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    Philips respironics has identified an issue where a non-conforming part (side panel) was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module (part number 109677). the issue results in the inability to connect the bipap a40 device to the detachable battery module during setup before putting the ventilator into operation on a user; therefore, there is no safety risk to the patient. the impacted bipap a40 units continue to work properly in configurations without the detachable battery module. a non-conforming part was utilized on the bipap a40 that affects the mechanical connection between the bipap a40 and the detachable battery module.
  • Action
    1. Complete the inspection of the devices for the potentially faulty side panel per the inspection instructions provided with the letter. 2. Complete and return Business Reply Form (BRF) and list the total quantity inspected, the quantity of correct devices, and the quantity of incorrect devices. 3. Contact your local Customer Service who will provide direction on how to return your device(s) for any confirmed faulty side panel replacement.

Device

BiPAP A 40 Ventilatory Support System; Detachable Battery Module, USA/INTL
  • Model / Serial
    BiPAP A 40 Ventilatory Support SystemProduct code: 1111171Detachable Battery Module, USA/INTLProduct code: 1096770ARTG number: 200289
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA