FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BIRTHING BED
MDR report key: 3222035
·
Received July 5, 2013
Report
- Report Number
- 1824206-2013-03356
- Event Type
- Malfunction
- Date Received
- July 5, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 10, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 IS NOT HOLDING. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 308251 | AFFINITY BIRTHING BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |