FDA Adverse Event
Malfunction
Summary report: N
3002 SECURE
MDR report key: 2113480
·
Received May 25, 2011
Report
- Report Number
- 1831750-2011-05091
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 28, 2011
- Report Date
- April 28, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: INTERMITTENT SCALE/ BED EXIT FUNCTIONS DUE TO MALFUNCTIONING FOOTBOARD PCB BOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE SCALE SYSTEM WAS NOT WORKING CORRECTLY. IT IS UNK IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3002 SECURE | A/C POWER HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |