FDA Adverse Event
Malfunction
Summary report: N
CCU BED
MDR report key: 2233264
·
Received July 22, 2011
Report
- Report Number
- 1824206-2011-03890
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 5, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND A BROKEN WELD ON THE PIVOT ARM. HE REPLACED THE SIDERAIL TO REPAIR THE BED.
Description of Event or Problem · 1
INFO REC'D INDICATES THE RIGHT SIDERAIL WILL NOT ROTATED AND LOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CCU BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |