FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 2182101
·
Received June 23, 2011
Report
- Report Number
- 3015876-2011-00491
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K902288
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): PHYSIO-CONTROL PROVIDED TECHNICAL ASSISTANCE TO THE CUSTOMER, RECOMMENDED REPLACEMENT OF THE POWER CONVERSION PCB ASSEMBLY, AND PROVIDED THE NECESSARY PART NUMBER FOR THE PCB ASSEMBLY. THE DEVICE WILL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD GIVE A FAULT MESSAGE ON THE SCREEN WHEN TRYING TO CHARGE FOR DEFIBRILLATION THERAPY. WHEN THE MESSAGE APPEARED, THE DEVICE WOULD NOT CHARGE FOR DEFIBRILLATION THERAPY. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | PHYSIO-CONTROL, INC. | 9P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |