FDA Adverse Event
Malfunction
Summary report: N
4 MOTOR ADVANCE BED
MDR report key: 2072062
·
Received April 21, 2011
Report
- Report Number
- 1824206-2011-02316
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO INSPECT THE RETRACTING FRAME FOR BROKEN WELDS OR COVERS THAT COULD BE BENT OR DAMAGED. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNT'S BIOMED ALLEGED THAT THE HEAD SECTION SLAMMED DOWN WHEN THE BED WAS IN THE CHAIR POSITION. A PT WAS IN THE BED AND THERE WERE NO INJURIES. WHEN HE ATTEMPTS TO OPERATE THE CHAIR IN FUNCTION, A LOUD GRINDING NOISE IS HEARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4 MOTOR ADVANCE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |