FDA Adverse Event
Malfunction
Summary report: N
ADVANCED BED
MDR report key: 3883960
·
Received February 14, 2014
Report
- Report Number
- 1824206-2014-00429
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 16, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE CASTER WHEEL IS WORN. THE TECHNICIAN REPLACED THE BRAKE CASTER WHEEL TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BRAKE CASTER WHEEL WILL NOT HOLD. THE BED IS LOCATED IN THE BED SHOP OF THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98191 | ADVANCED BED | AC POWERED ADJUSTABLE HOSPITALB ED | FNL | HILL-ROM INC. | 1105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |