Events

Recall of LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connector

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Physio-Control Australia 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-01389-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01389-1
  • 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
    Physio-control is notifying customers of an issue with the artwork on the defibrillation electrodes, as manufactured by cardinal health, does not meet physio-control’s specifications, and shows incorrect electrode placement for an infant. there is no issue with the performance or function of the defibrillation electrodes; this is limited to incorrect artwork on the defibrillation electrodes within the packaging. if the user incorrectly places the defibrillation electrodes it may result in ineffective energy delivery to the patient. this may result in failure to defibrillate and serious injury or death. there have been no reports of injuries associated with this issue.
  • Action
    Users are advised to inspect the "Electrode pouch and box labelling" and the "Electrode Starter Kit box labelling" to determine if the electrodes are affected. Users are advised to place of copy of the correct electrode packaging and labelling with each affected AED, until the electrodes have been replaced by Physio- Control.

Device

LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED...
  • Model / Serial
    LIFEPAK EXPRESS AED, LIFEPAK CR Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED with a pink connectorElectrodeCatalogue Number: 111401-000016MIN: 3202380-006Lot Numbers: 713609, 717912, 713904, 718033, 715008 and 719323Electrode Start KitsCatalogue Number: 11101-000017MIN: 3202784-009Lot Numbers: 45932237, 46042286, 45979590, 46050960, 45979954, 46052545, 46007867, 46061770, 46023185, 46063054, 46023823 and 46078012ARTG Number: 232970
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Physio-Control Australia Pty Ltd

Manufacturer

Physio-Control Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA