FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1171939
·
Received September 19, 2008
Report
- Report Number
- 3015876-2008-01221
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, WHILE INSPECTING THE DEVICE AND WHEN THE DEVICE WAS TURNED ON, THERE WERE NO VOICE PROMPTS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIBRILLATOR | LDD | PHYSIO-CONTROL, INC. | CRPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |