FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1003745
·
Received February 22, 2008
Report
- Report Number
- 3015876-2008-00084
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- November 28, 2007
- Report Date
- November 28, 2007
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K902288
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL CONTACTED THE CUSTOMER AND STATED THAT THE REFERENCED ACCESSORY IS NOT REPAIRABLE AND MADE AN OFFER TO CUSTOMER TO REPLACE CABLE OR ENTIRE ADAPTER ACCESSORY.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WITH A DEFIBRILLATION ADAPTER DOES NOT TRANSFER ENERGY TO A DEFIBRILLATION METER. DEVICE REPORTEDLY OPERATES PROPERLY WITHOUT THE ADAPTER, WITH STANDARD PADDLES. REPORTER IS REQUESTING REPAIR OF ADAPTER. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AS A RESULT OF THE DEVICE USE.
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 |