FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 2030547
·
Received March 22, 2011
Report
- Report Number
- 1824206-2011-01768
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH REPLACED THE CASTER TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BRAKE CASTER WOULD ENGAGE THE BRAKE ON THE WHEEL BUT THE SWIVEL PORTION WASN'T HOLDING COMPLETELY TIGHT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |