FDA Adverse Event
Malfunction
Summary report: N
XL BARIATRIC BED
MDR report key: 3882802
·
Received February 20, 2014
Report
- Report Number
- 1824206-2014-00559
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 24, 2014
- Report Date
- January 24, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- OSI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THAT THE BRAKE/NEUTRAL MECHANISM INSIDE THE BRAKE CASTERS ON BOTH SIDES AT THE HEAD END OF THE BED WERE BROKEN. THE TECH REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECH REPORTED THE BRAKES AT THE FOOT END OF THE BED ARE NOT HOLDING. THE BED WAS LOCATED IN THE HILL-ROM SVC CTR. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107207 | XL BARIATRIC BED | BARIATRIC BED | OSI | HILL-ROM, INC. | 610B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |