FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 2111086
·
Received May 19, 2011
Report
- Report Number
- 3015876-2011-00403
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 2011
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. 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
IT WAS REPORTED THAT THE DEVICE INTERMITTENTLY HAD A WHITE SCREEN WHEN TURNED ON USING DC POWER. THIS IS INDICATIVE OF A LOCK-UP FAILURE. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |