Device product
The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
Z-0761-2017
Product summary
- Event
- Event 75743
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1399 units (866 in the US and 533 outside US)
- Official record key
device-enforcement:Z-0761-2017
Official wording
Reason: Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.
Code information: This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.