Recall Z-1656-2008 ยท MKJ Automated External Defibrillators (Non-Wearable)
Physio Control, Inc.
LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. The defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft,
| Date | Sep 16, 2008 (initiated Feb 27, 2008) |
| Status | Terminated |
| Reason | Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed. |
| Root cause | Component change control |
| Action | On February 27, 2008 the firm sent a URGENT MEDICAL DEVICE NOTIFICATION letter to consignees advising of the issue. The letter states the firm is performing accelerated function testing and that a follow up notification will be sent if the firm's final test results indicate further action is necessary. The letter recommends consignees "Continue to use your LIFEPAK 1000 defibrillator/monitor Set your device to Auto-Analyze Contact Physio-Control immediately if your display begins to dim or goes blank. What to do if the display goes blank while in use: 1. Continue to use the device to tre |
| Quantity | 1,647 total - 426 US, 1,221 international |
| Distribution | Worldwide Distribution --- including USA and countries of Netherlands, Germany, Australia, Hong Kong, Barbados and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042404 | LIFEPAK, MODEL 1000 Medtronic Emergency Response Systems, Inc., Dec 22, 2005 |