FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2072929
·
Received March 31, 2011
Report
- Report Number
- 1824206-2011-01952
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT BRACKET WAS SENT TO THE ACCOUNT. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE RIGHT HAND BRACKET WELDMENT THAT ATTACHES TO THE FOOT SECTION SLEEP DECK MODULE OF THE BED IS MISSING THE ANGLE BRACKET. THIS CAUSES THE FOOT SECTION MODULE TO SLIDE OUT WHEN IT LEANED AGAINST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |