FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1011947
·
Received March 11, 2008
Report
- Report Number
- 3015876-2008-00163
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 12, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL IS INVESTIGATING THE REPORTED INCIDENT.
Description of Event or Problem · 1
FOUND IN TESTING. ACCORDING TO THE REPORTER, THE DEVICE INTERMITTENTLY WILL NOT POWER ON USING EITHER AC OR DC POWER.
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 |