FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 15 MONITOR/DEFIBRILLATOR
MDR report key: 2151375
·
Received June 8, 2011
Report
- Report Number
- 3015876-2011-00457
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 12, 2011
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- MKJ
- PMA / PMN Number
- K082937
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL ANTICIPATES THE DEVICE RETURN TO THE MANUFACTURING FACILITY AND CONTINUES TO INVESTIGATE THE REPORTED EVENT. 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
DURING THE DEVICE IN-SERVICE, IT WAS REPORTED THAT IT FROZE, LOST POWER AND RESTARTED MULTIPLE TIMES. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 15 MONITOR/DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC | 15 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |