FDA Adverse Event
Malfunction
Summary report: N
GOBED II
MDR report key: 2837981
·
Received October 17, 2012
Report
- Report Number
- 1831750-2012-10934
- Event Type
- Malfunction
- Date Received
- October 17, 2012
- Date of Event
- September 20, 2012
- Report Date
- September 20, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: WHEELS WERE DELAMINATING FROM CASTERS. CONCLUSION: REPAIR PARTS ORDERED AND SENT TO CUSTOMER FOR INSTALLATION.
Description of Event or Problem · 1
IT WAS REPORTED BYS SERVICE REPORT THAT THE GO BED WHEELS WERE SPLITTING. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW 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 | GOBED II | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL28EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |