FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BIRTHING BED
MDR report key: 3072273
·
Received April 4, 2013
Report
- Report Number
- 1824206-2013-01912
- Event Type
- Malfunction
- Date Received
- April 4, 2013
- Date of Event
- March 12, 2013
- Report Date
- March 12, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS DECIDED NOT TO REPAIR THE BED DUE TO THE AGE OF THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATED THE BRAKE CASTERS WERE NOT HOLDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139565 | AFFINITY BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |