FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 3823222
·
Received February 27, 2014
Report
- Report Number
- 1824206-2014-00629
- Event Type
- Malfunction
- Date Received
- February 27, 2014
- Date of Event
- January 29, 2014
- Report Date
- January 29, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND BRAKE AND BRAKE STEER CASTERS ARE WORN. THE TECH REPLACED THE BRAKE STEER CASTERS AND BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BRAKES ARE NOT HOLDING, THE BED STILL ROLLS WHEN THE BRAKE IS SET. THE BED IS LOCATED IN THE STORAGE AREA AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122631 | ADVANCE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 1165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |