Events

Recall of Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty 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-01429-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01429-1
  • 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
    Medtronic has identified specific units of lithium ion batteries which are used in puritan bennett 980 ventilators, following reports that the batteries may not fully charge after installation. the scope of this notice includes batteries that were manufactured between december 2013 and may 2017, with serial numbers begin with 1201xxxxxx through 1712xxxxxxa functional battery installed in the pb980 ventilator automatically recharges when the battery depletes and the ventilator is connected to ac power. in the case of a battery with incorrect firmware, it may fail to fully charge. this situation does not impact the ventilator’s operation when it is connected to ac power. however, if the ventilator is operated on battery power alone, this situation could limit the amount of time the ventilator is operational.
  • Action
    Notify all care environments in which the PB980 ventilators are used about this notification. If PB980 ventilators have been distributed to other persons or facilities, promptly forward a copy of this letter to them. Complete the attached form and return it as directed to confirm your receipt and understanding of this information. Medtronic service engineers will inspect batteries in the field during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced. The PB980 ventilator may continue to be used as described in the Operator’s Manual.

Device

Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators
  • Model / Serial
    Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 VentilatorsProduct Code: 10086042Serial Numbers beginning with 1201xxxxx through 1712xxxxxxARTG Number: 221452
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA