FDA Adverse Event
Malfunction
Summary report: N
JERON
MDR report key: 364634
·
Received November 28, 2001
Report
- Report Number
- 364634
- Event Type
- Malfunction
- Date Received
- November 28, 2001
- Report Date
- September 28, 2001
- Manufacturer
- JERON ELECTRONIC SYSTEMS INC.
- Product Code
- ILQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COUNCIL BUTTON ON THE 6420 AND 6422 BEDSIDE STATION STICKS, CAUSING THE CALL BUTTON TO BECOME INACTIVE. WHAT HAPPENS IS THAT THE POST, THAT ARE MELTED TO HOLD THE PUSH BUTTON SWITCH TO THE P.C. BD. BROKE. THIS CAUSES THE SWITCH TO ROCK TO ONE SIDE AND THE BUTTON BINDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53626 | JERON | PRO ALERT 640 NURSE CALL SYSTEM | ILQ | JERON ELECTRONIC SYSTEMS INC. | 6420 | NA | |
| 53627 | JERON | PRO ALERT 640 NURSE CALL SYSTEM | ILQ | JERON ELECTRONIC SYSTEMS INC | 6422 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |