FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 3844782
·
Received March 12, 2014
Report
- Report Number
- 1824206-2014-00814
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 12, 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 WHEEL ON THE BRAKE CASTER IS WORN OUT MOST LIKELY DUE TO NORMAL WEAR AND TEAR. THE TECHNICIAN REPLACED THE WHEEL ON THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BRAKE DOES NOT HOLD. THE BED WAS LOCATED IN THE BED SHOP AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149259 | ADVANCE BED | A/C POWERED ADJUSTABLE HOSP. BED | FNL | HILL-ROM, INC. | 1105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |