FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BED
MDR report key: 2221754
·
Received August 15, 2011
Report
- Report Number
- 1831750-2011-08654
- Event Type
- Malfunction
- Date Received
- August 15, 2011
- Date of Event
- July 19, 2011
- Report Date
- July 19, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: HANDLE.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE HEAD LEFT RELEASE HANDLE WAS BROKEN AND THE SIDE RAIL WAS STUCK IN THE INTERMEDIATE POSITION. THE CUSTOMER COULD NOT DETERMINE 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 | SECURE 3 MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002S3EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |