FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 2170758
·
Received June 22, 2011
Report
- Report Number
- 1824206-2011-03396
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 11, 2011
- Report Date
- June 2, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT ORDERED REPLACEMENT SIDERAIL TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE SIDE RAIL FUNCTIONS ARE NOT WORKING DUE TO FRAYED CABLING ON BOTH SIDERAILS. BARE WIRING IS EXPOSED AROUND THE LOWER PIVOT POINT OF THE SIDERAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTA BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |