The Australia Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Philips HeartStart XL+ Defibrillator/Monitor manufactured by Philips Medical Systems. The affected HeartStart XL+ Defibrillator/Monitor units include serial numbers within the following ranges:

• USO1100100 to USD1101095
• US11201096 to USD1203968
• US11303969 to USD1309471
• US11409472 to US61414022

The manufacturer has identified the following XL+ software and hardware issues:-

• Software issues:
  • The XL+ may fail to complete the power on sequence and continuously reboot.
  • The XL+ may either fail to power up or may shut down unexpectedly.
  • The XL+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption.
  • The XL+ may fail to generate verbal prompts in Automated External Defibrillator (AED) mode.
• Hardware issues:
  • The XL+ may have been manufactured with a speaker that may fail.
  • The battery may not seat properly causing the XL+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery.
  • The XL+ exceeds the allowable radiated emissions level for Class B CISPR11.
  • The XL+ ECG signal from leads could be lost and unrecoverable.
  • The XL+ SpO2 signal may lose communication and cause the device to reboot.
  • The XL+ battery detection system may be disrupted and cause a false low battery alarm

According to the alert, the manufacturer will contact customers with affected devices to arrange for installation of the software and hardware upgrades. In the interim, the manufacturer advises users that they can continue to use their XL+ prior to receiving the software and hardware upgrades, provided they should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits any of these issues.

For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2015-RN-00588-1

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

Posted on 6 July 2015