FDA Adverse Event
Malfunction
Summary report: N
PIC-50
MDR report key: 726648
·
Received June 12, 2006
Report
- Report Number
- 1418729-2006-00073
- Event Type
- Malfunction
- Date Received
- June 12, 2006
- Report Date
- July 22, 2005
- Manufacturer
- MRL, INC. A WELCH ALLYN COMPANY
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION OF THE DEVICE INDICATED THAT THE REPORTED PROBLEM WAS CAUSED KBY INTERMITTENT CONNECTION IN U25 OF THE DEFIB BOARD. THE DEVICE WAS REPAIRED PER OUR PREVENTATIVE MAINTENANCE PROCEDURES SPECIFFICALLY DEVELOPED TO RESOLVE "DEFIB COMM ERROR". AFTER PERFORMING THE PROCEDURE, THE "DEFIB COMM ERROR" CLEARED AND COULD NOT BE REPRODUCED. THE DEVICE WAS TESTED AND FOUND PERFORM IN ACCORDANCE WITH IT SPECIFICATIONS.
Description of Event or Problem · 1
UNIT DISPLAYS 'DEFIB COMM ERROR'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIC-50 | DEFIBRILLATOR/ECG MONITOR | MKJ | MRL, INC. A WELCH ALLYN COMPANY | PIC-50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |