FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BIRTHING BED
MDR report key: 3031349
·
Received March 5, 2013
Report
- Report Number
- 1824206-2013-01243
- Event Type
- Malfunction
- Date Received
- March 5, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BRAKE CASTER WOULD NOT UNLOCK. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94895 | AFFINITY BIRTHING BED | BIRTHING BED | HDD | HILL-ROM INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |