Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its HeartStart XL+ Defibrillator/Monitor (Model No.: 861290). The affected serial number ranges are shown below:
- USO1100106 to USO1100372
- USN1100376 to USN1100960
- USD1100961 to USD1101095
- US11201096 to US11201186
- US21201187 to US21201239
- US31201240 to US31201537
- US41201538 to US41201585
- US51201586 to US51201721
- US61201722 to US61201924
- US71201925 to US71202048
- US81202049 to US81202168
- US91202169 to US91202514
- USO1202515 to USO1202990
- USN1202991 to USN1203537
- USD1203538 to USD1203968
- US11303969 to US11303972
- US21303980 to US21304488
- US31304489 to US31305042
- US41305043 to US41305295
- US51305296 to US51305450
- US61305451 to US61306138
- US71306139 to US71306542
- US81306543 to US81306998
- US91306999 to US91307261
- USO1307306 to USO1307458
- USN1307616 to USN1308423
- USD1308424 to USD1309471
- US11409472 to US11410212
- US21410213 to US21410563
According to the manufacturer, a software communication failure on the HeartStart XL+ that occurs during an automated ready-for-use test or at turn-on may lock the user out of clinical mode, which may delay therapy.
The manufacturer is providing a software upgrade to users with affected devices.
The manufacturer advises affected users to take the following actions:-
- While awaiting the software upgrade, users may continue to use the HeartStart XL+ unless the device exhibits a Red X, presents an audio chirp and displays the user message: "Equipment Disabled: Therapy". This is an indicator that the device self-test has detected the problem and is not ready for use.
- In the case the problem cannot be resolved by running Op-Check, users should identify a readily available backup defibrillator to use in the event the affected HeartStart XL+ exhibits the communication failure.
According to the manufacturer, the affected products were distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 April 2014