FDA Adverse Event
Malfunction
Summary report: N
ELECTRIC MED/SURG BED
MDR report key: 3932704
·
Received July 14, 2014
Report
- Report Number
- 0001831750-2014-03154
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THERE WAS REDUCTION IN BRAKE FORCE DUE TO THE RUBBER MATERIAL OF THE CASTER BEING DAMAGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 409084 | ELECTRIC MED/SURG BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |