FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2151414
·
Received June 8, 2011
Report
- Report Number
- 1824206-2011-03146
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THAT THE MOUNTING BRACKET WAS BENT. HE REPLACED THE MOUNTING BRACKET TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE RIGHT HEAD SIDERAIL WILL NOT LATCH.
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 |