FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1112136
·
Received August 6, 2008
Report
- Report Number
- 3015876-2008-00871
- Event Type
- Malfunction
- Date Received
- August 6, 2008
- Date of Event
- May 12, 2008
- Report Date
- May 19, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL IS INVESTIGATING THE REPORTED EVENT.
Description of Event or Problem · 1
PHYSIO-CONTROL WAS PERFORMING AN EVAL OF A CUSTOMER RETURNED DEVICE. A REVIEW OF THE DEVIC'S DATA DOWNLOAD SHOWS INDICATIONS THAT DEVICE OPERATION LOCKED UP DURING THE 3:00 AM SELFTEST IN 2008, AND SUBSEQUENTLY DEPLETED THE DEVICE'S INTERNAL BATTERY AND THE CHARGE-PAK BATTERY CHARGER.
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 |