Events

Recall of Patient Data Module (PDM) Used with CARESCAPE Monitor B850, B650, or B450 (Multiparameter Patient Monitor)

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-2014-RN-00945-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-08-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00945-1
  • 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
    Ge healthcare has recently become aware of a potential safety issue due to ecg performance issues following a disconnect/reconnect cycle with the patient data module (pdm), when used with the carescape bx50 monitors. if the pdm is quickly disconnected and reconnected (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 analysed incorrectly and the alarms for serious conditions may not be triggered appropriately. 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. 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.
  • Action
    To prevent the occurrence of the issues, when physically disconnecting the PDM from the CARESCAPETM Monitor Bx50 users should wait a minimum of 10 seconds before reconnecting. If users notice the ECG heart rate value appears to be half of the patient's physiologic condition or the patient waveforms (ECG, SpO2, Invasive Blood Pressure, or Impedance Respiration) appear to show every other pulse, follow these steps to correct the parameter and alarm issues: 1)Physically disconnect the PDM E-port cable or un-dock the PDM from the host monitor. 2)Wait a minimum of 10 seconds and then reconnect or re-dock the PDM. When the PDM re-establishes communication with the Bx50, the parameters and alarms will operate as expected. GE Healthcare will also implement a permanent software fix.This action has been closed-out on 15/08/2016.

Device

Patient Data Module (PDM) Used with CARESCAPE Monitor B850, B650, or B450 (Multiparameter Patient...
  • Model / Serial
    Patient Data Module (PDM) Used with CARESCAPE Monitor B850, B650, or B450 (Multiparameter Patient Monitor)All versions of PDM software v2.2 or lowerARTG number: 92726
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd