Physio-Control has identified a software malfunction in the LIFEPAK 1000 defibrillator which results in the Readiness Display indicating a low battery charge when it should indicate a very low battery charge. When the battery reaches very low battery charge, the device will correctly indicate this state in the Readiness Display. However, due to the software malfunction, following the next daily auto self-test, the Readiness Display will incorrectly indicate a low battery charge. Batteries at both low and very low state of charge must be replaced with a fully charged battery.
All LIFEPAK 1000 defibrillators with software version 2.42 or lower are impacted by this issue.
Customers with devices using batteries that are greater than 3 years of age, or who use their
devices frequently are more susceptible to this issue.
Users are advised that it is important that you always carry a spare fully-charged battery, as
stated in the manufacturer’s Operating Instructions.
ACTION OR RECOMMENDATIONS
The HPRA advises that users:
- Follow the actions outlined by the manufacturer in the attached Field Safety Notice.
- - Verify the readiness of the device and determine the battery’s actual charge.
- - Always carry a spare fully-charged battery, as stated in the Operating Instructions.
- Replace the battery immediately if the LED indicates that the battery is at low charge or very low charge.
- Forward this Safety Notice to all those that need to be aware within your organisation or to any organisation / person where these devices have been transferred. Please maintain an awareness of this notice for an appropriate time period.