FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1051215
·
Received May 23, 2008
Report
- Report Number
- 3015876-2008-00531
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 18, 2008
- Report Date
- April 18, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE HLC'S WERE COMPLETELY DRAINED, AND THE CHARGE PAK WAS MEASURED AT 9.5 VOLTS. THERE WAS NO FURTHER EXPLANATION OF WHY THE DEVICE FAILED. THE ROOT CAUSE FOR THE REPORTED FAILURE COULD NOT BE DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A LOW BATTERY CAPACITY. THERE WAS NO PT USE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | CRPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |