FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 3033188
·
Received March 1, 2013
Report
- Report Number
- 1824206-2013-01198
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 1, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BRAKE CASTER RATCHETS SLIGHTLY WHILE IN BRAKE MODE. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90291 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |