FDA Adverse Event
Malfunction
Summary report: N
4 MOTOR ADVANCE BED
MDR report key: 2221766
·
Received August 17, 2011
Report
- Report Number
- 1824206-2011-04351
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT SIDERAIL WAS SENT TO THE ACCOUNT TO REPAIR THE BED. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNTS BIOMED STATED THE LEFT SIDERAIL HAS A BROKEN WELD AND WILL NOT LATCH IN THE UP POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 MOTOR ADVANCE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1105 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |