FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 2142579
·
Received June 21, 2011
Report
- Report Number
- 1824206-2011-03348
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 31, 2011
- Report Date
- May 31, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE BIOMED STATED THE BED HAS A HIGH GROUND LEAKAGE READING BUT THE INDICATOR IS NOT FLASHING GROUND LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTA BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |