Events

Recall of PATIENT DATA MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    58986
  • Event Risk Class
    II
  • Event Initiated Date
    2014-08-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The following issue is being addressed by ge healthcare file no. fmi 36107: if the pdm is quickly disconnected and reconnected (a less than 10 second cycle) from a carescape bx50 monitor following a "patient discharge" or during active monitoring the ecg waveform and its associated waveform parameters could be analyzed incorrectly. the ecg heart rate (hr) parameter data the ecg waveform analysis and other ecg parameter measurements are displayed at values that will be less than the actual patient's physiologic condition. as a result of the abnormal analysis of data the alarms for serious conditions may not be triggered appropriately. the issue potentially affects heart rate ecg st segment analysis 12 lead ecg analysis ecg spo2 respiration and invasive blood pressure waveforms both locally and at cic and data displayed at cic may show data drop out. neither bedside nor cic data can reliably represent the parameters being measured. if your facility uses the pdm only with transport pro or solar monitors the issue does not exist.

Device

PATIENT DATA MODULE

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)