The Australia Therapeutic Goods Administration (TGA) posted a medical device safety alert concerning Panda iRes Warmers integrated with Nellcor SpO2, manufactured by GE Healthcare.

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.

The manufacturer 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:

• 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.
• 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.
• 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. 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.
• If the test does NOT activate a 'Low Pulse Rate' alarm, remove the warmer from clinical service and contact the local GE Healthcare Service Representative.

For details, please refer to TGA website:
http://www.tga.gov.au/SARA/arn-detail.aspx?k=RC-2014-RN-00450-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 22 April 2014