Events

Recall of Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Welch Allyn Australia Pty Limited.

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-2013-RN-01124-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01124-1
  • 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
    Internal product testing conducted by welch allyn has identified fault conditions relating to electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this event were to occur, the device would either present an error screen instructing the user to restart the monitor, or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights, and in either case, the issue would be resolved by restarting (power cycling) the monitor. this issue is more likely to occur at higher energies such as 5kv. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.
  • Action
    Welch Allyn is providing work around instructions for users to follow if the error messages are displayed. A software update will be implemented to permanently correct the issue.

Device

Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)
  • Model / Serial
    Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)Model Numbers: 802LTAN, 802LT0NSerial Numbers: KA009946 to KA027084 and KL014918 to KL019440ARTG Number: 123809
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited