Events

Recall of Panda iRes Warmers integrated with Nellcor SpO2

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-00450-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00450-1
  • 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
    There may be a loss of internal communication that manages the user-adjusted nellcor spo2 alarm settings of the affected giraffe and panda ires warmer systems with nellcor spo2 listed above. if the issue exists, the alarms may not activate as expected, which can result in false positive or false negative saturation and pulse rate alarm notifications to the caregiver. the patient’s oxygen saturation and pulse rate values are accurate, as displayed; however, the displayed user-set alarm limits may be different than the actual alarm limits used for alarm activation. all other clinical functionality of the warmer is unaffected.This alarm failure is caused by a software issue that does not detect a loss of internal communication that manages the user-adjusted nellcor spo2 alarm settings.
  • Action
    GE Healthcare will correct all affected systems with a software revision. Customers may continue to use the system provided they follow the GE recommended actions as follows: 1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement. 2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator. 3) If the test activates a ‘Low Pulse Rate’ alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service. PLEASE NOTE: Alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed. 4) If the test does NOT activate a ‘Low Pulse Rate’ alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.

Device

Panda iRes Warmers integrated with Nellcor SpO2

Manufacturer

GE Healthcare Australia Pty Ltd