FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
MDR report key: 2780881
·
Received October 10, 2012
Report
- Report Number
- 3015876-2012-00752
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 12, 2012
- Report Date
- September 12, 2012
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K063119
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES AND IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A SHORTED INTEGRATED CIRCUIT CHIP, DESIGNATOR U61. SPECIFICALLY PIN 25 OF U61 HAD A 80 OHM SHORT TO GROUND.
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER AND USER INTERFACE PCB ASSEMBLIES AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEIR DEVICE WOULD NOT COMPLETE THE BOOT UP CYCLE WHEN POWERING THE DEVICE ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) | LDD | PHYSIO-CONTROL, INC | 20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |