FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1160766
·
Received September 8, 2008
Report
- Report Number
- 3015876-2008-01076
- Event Type
- Malfunction
- Date Received
- September 8, 2008
- Date of Event
- July 29, 2008
- Report Date
- August 7, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL RECOMMENDED CUSTOMER TRYING ANOTHER SET OF PADDLES, AND CONTACTING THEIR LOCAL BIOMED, IF THE PROBLEM REOCCURRED. PHYSIO-CONTROL HAS ATTEMPTED SEVERAL TIMES TO CONTACT THE CUSTOMER, TO CONFIRM RESOLUTION OF THE REPORTED FAILURE. TO THIS DATE, THE CUSTOMER HAS NOT RETURNED ANY OF PHYSIO-CONTROL'S COMMUNICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN CHARGING TO 50 JOULES USING INTERNAL PADDLES, THE DEVICE AUTOMATICALLY DELIVERS ENERGY WITHOUT PRESSING THE SHOCK BUTTON ON EITHER THE DEVICE OR THE PADDLE HANDLES. THE ENERGY DELIVERY SHOWS ON THE SCREEN. THE DEVICE WAS HOOKED TO A PT AT THE TIME OF THIS EVENT; HOWEVER, THE CUSTOMER DID NOT PROVIDE ANY INFO ON THE PT'S OUTCOME.
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 | UNK |