FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1052219
·
Received May 21, 2008
Report
- Report Number
- 3015876-2008-00522
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- April 25, 2008
- Report Date
- April 25, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND DETERMINED THAT ROOT CAUSE FOR THE MISSING VOICE PROMPTS WAS AN ELECTRICAL OPEN IN THE SPEAKER COIL.
Description of Event or Problem · 1
PHYSIO-CONTROL WAS INSPECTING AND TESTING A CUSTOMER'S REPLACED DEVICE. PHYSIO OBSERVED THAT THE DEVICE HAD NO VOICE PROMPTS DURING AED OPERATION. THERE WAS NO PT INVOLVED WITH THE REPORTED INCIDENT.
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 |