FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2933467
·
Received December 21, 2012
Report
- Report Number
- 1831750-2012-13151
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 29, 2012
- Report Date
- November 29, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
MOTION INTERRUPT PAN BOLTED TOO TIGHT. CPU BOARD NOT BURNED-IN AFTER REPLACEMENT BY CUSTOMER. SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE MOTION INTERRUPT PAN AND BED LIFT WERE STUCK AND THE BED EXIT WAS NOT FUNCTIONING. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |