Device product
The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.
Z-1257-2017
Product summary
- Event
- Event 76252
- Status
- Terminated
- Classification
- Class I
- Quantity
- total 133,330 units (50,046 units in the US)
- Official record key
device-enforcement:Z-1257-2017
Official wording
Reason: The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
Code information: Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.
Distribution pattern: Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.
Derived failure modes
-
Unknown
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.