Important Safety Alerts

The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom and the Health Canada posted a medical device safety alert concerning HeartStart XL Defibrillator/Monitor battery M3516A, manufactured by Philips Healthcare. The affected products were labeled with "Made in Taiwan" and has "R-2011-12" as Date of Manufacture code.

According to Philips, the affected battery may not trigger a low battery alarm on the HeartStart XL Defibrillator/Monitor (M4735A). In this case, if the HeartStart XL is used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone.

There is a potential for patient harm if the XL shuts down or becomes inoperable when in clinical use for providing therapy. Therefore, Philips recommends the following actions:

• Operate the XL with AC power instead of battery power alone.
• If it is needed to operate the XL on battery power alone, ensure the battery is from a different Date of Manufacture (it must not have the R-2011-12 Date of Manufacture code).
• If unable to operate with AC power alone or locate a battery with a different Date of Manufacture than that identified above, use an alternative source for treatment or therapy (i.e., backup defibrillator/monitor).

According to the local supplier, the affected products have been distributed in Hong Kong.

For details, please refer to the MHRA and Health Canada websites as below:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON185586
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2012-eng.php

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

Posted on 3 October 2012