FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 1 AND 2 BED
MDR report key: 2841731
·
Received October 22, 2012
Report
- Report Number
- 1824206-2012-06724
- Event Type
- Malfunction
- Date Received
- October 22, 2012
- Date of Event
- October 2, 2012
- Report Date
- October 2, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THE BRAKE CASTERS SWIVEL WHILE IN BRAKE MODE. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 1 AND 2 BED | BIRTHING BED | HDD | HILL-ROM INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |