FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1894614
·
Received November 4, 2010
Report
- Report Number
- 3015876-2010-01224
- Event Type
- Malfunction
- Date Received
- November 4, 2010
- Date of Event
- October 7, 2010
- Report Date
- October 7, 2010
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THE CAUSE OF THE FAILURE TO BE A SHORTED DIODE, DESIGNATOR CR30.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE SERVICE INDICATION AND LOGGED EVENT CODES IN THE MEMORY. PHYSIO-CONTROL'S FURTHER INVESTIGATION FOUND A CRITICAL FAILURE THAT PREVENTED DEFIBRILLATION THERAPY DELIVERY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |