FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 2221765
·
Received August 17, 2011
Report
- Report Number
- 1824206-2011-04350
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 2, 2011
- 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
REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE REVERSE TRENDELENBURG BURG FUNCTION WILL NOT OPERATE BUT THE HI/LOW FUNCTION IS WORKING. THE ACCOUNTS ENGINEER HAS REPLACED THE FOOT PANELS AND RESEATED THE CONNECTION ON THE FIB BOARD BUT THE ISSUE REMAINS.
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 | UNK |