Events

Recall of Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifunction patient monitoring)All PDMs produced from April 2007 through June 2010

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by GE Healthcare 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-2013-RN-01255-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01255-1
  • 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
    Fluid can pass through the seals in the top cover and come into contact with energised contacts in the circuit board. this can result in heat buildup, smoke, and discoloration. this heat buildup could potentially result in thermal injury to a patient or a caregiver.
  • Action
    GE Healthcare is advising users to inspect the top cover for signs of heat buildup or discolouration. Remove from use if any evidence of damage is observed. GE is advising users to refrain from spraying fluid onto device. A new cover will be installed on all affected devices as a permanent fix when available. This action has been closed-out on 11/02/2016.

Device

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifuncti...
  • Model / Serial
    Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i, MacLab / ComboLab (Multifunction patient monitoring)All PDMs produced from April 2007 through June 2010Serial Numbers: SA30713XXXXXX to SA31026XXXXXXARTG Number: 118982
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd