Events

Recall of Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)

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-01234-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01234-1
  • 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
    The spring inside the mounting latch can become dislodged causing the pdm not to latch properly resulting in an unexpected loss of patient monitoring function. this may also result in the pdm falling onto a patient or caregiver. warning messages are displayed indicating patient parameters which have been disconnected and also, a three short burst alarm is issued and repeated if acknowledged.
  • Action
    GE Healthcare is advising users to refrain from mounting the monitor above a patient or caregiver and refrain from mounting the monitor at a downward facing angle. GE Healthcare will be installing a new latch on all units once available. This action has been closed-out on 10/02/2016.

Device

Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifun...
  • Model / Serial
    Patient Data Module (PDM) used with B850, B650, B450, Solar 8000i and MacLab / ComboLab (multifunction patient monitor module)Product Codes: SA3, SG5All monitors produced from April 2007 to December 2012.Serial Numbers: SA030713XXXXXX to SA31252XXXXXX and SG050713XXXXXX to SG51252XXXXXXARTG Number: 118982
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd