FDA Adverse Event
Malfunction
Summary report: N
PHYSIO-CONTROL LIFEPAK 90
MDR report key: 272517
·
Received April 4, 2000
Report
- Report Number
- 272517
- Event Type
- Malfunction
- Date Received
- April 4, 2000
- Date of Event
- February 22, 2000
- Report Date
- March 28, 2000
- Manufacturer
- PHYSIO-CONTROL
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DEFIBRILLATOR MALFUNCTIONED DURING A CARDIOVERSION PROCEDURE IN EP LAB ON 2/22/00. DEFIBRILLATOR FAILED TO DISCHARGE WHEN THE BUTTON WAS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHYSIO-CONTROL LIFEPAK 90 | DEFIBRILLATOR | LDD | PHYSIO-CONTROL | 805460-01 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |