FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 2922667
·
Received December 27, 2012
Report
- Report Number
- 1824206-2012-08640
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE SIDERAIL CENTER ARM WAS BROKEN AND THE MOUNTING BRACKET BENT. THE TECHNICIAN INDICATED IT LOOKS AS THOUGH THE SIDERAIL ABUSED. THE TECHNICIAN REPLACED THE SIDERAIL CENTER ARM AND MOUNTING BRACKET TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE SIDERAIL IS BROKEN OFF OF THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |