FDA Adverse Event
Malfunction
Summary report: N
GOBED+
MDR report key: 2841620
·
Received October 24, 2012
Report
- Report Number
- 1831750-2012-11146
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Date of Event
- September 26, 2012
- Report Date
- September 26, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
SIDERAIL RELEASE HANDLE BENT AND MISALIGNED.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD RIGHT SIDE RAIL WAS STUCK IN THE LOW POSITION. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GOBED+ | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL20E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |