FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 2080209
·
Received April 6, 2011
Report
- Report Number
- 1824206-2011-02042
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT VERIFIED THAT THE BED WAS NOT PLUGGED INTO AN ISOLATED POWER OUTLET. TECH ASKED THE ACCOUNT TO CHECK THE AC VOLTAGE AT P1 ON THE HIGH VOLTAGE BOARD ACROSS THE WHITE AND GREEN WIRES AND THE GREEN AND BLACK WIRES. NO FURTHER INFO IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE GROUND LOSS LED IS FLASHING. THE ACCOUNT STATED THAT THERE WERE NO INJURIES AND A PT WAS NOT IN THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |