FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2161090
·
Received July 5, 2011
Report
- Report Number
- 1824206-2011-03565
- Event Type
- Malfunction
- Date Received
- July 5, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT FOUND THE SIDERAIL MOUNTING BRACKET WAS BENT. HE STRAIGHTENED THE MOUNTING BRACKET TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED THE SIDERAIL WILL NOT LATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |