FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 1000 DEFIBRILLATOR
MDR report key: 2182030
·
Received June 22, 2011
Report
- Report Number
- 3015876-2011-00489
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- September 7, 2010
- Report Date
- May 23, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K042404
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). PHYSIO-CONTROL RECOMMENDED DEVICE REPAIR AND REPLACEMENT OF THE BATTERY. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
Description of Event or Problem · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT THE BATTERY WAS COMPLETELY DEPLETED. THE DEVICE DOWNLOAD SHOWED THAT IT HAD NO POWER AND UNABLE TO TURN ON FROM (B)(6) 2010 TO (B)(6) 2011 WHILE IN SERVICE. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 1000 DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | 1000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |