FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 2072569
·
Received April 21, 2011
Report
- Report Number
- 3015876-2011-00341
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 25, 2011
- Report Date
- March 25, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED NO AUDIO FAILURE. PHYSIO DETERMINED THE CAUSE OF THE MALFUNCTION TO BE DUE TO AN INTERMITTENT SPEAKER OUTPUT. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD NO VOICE PROMPTS. THERE WAS NO PATIENT USE ASSOCIATED WITH THE 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 |