FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2050435
·
Received March 15, 2011
Report
- Report Number
- 1824206-2011-01588
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 20, 2011
- Report Date
- February 20, 2011
- 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 SIDERAIL BRACKETS AND THE DAMPENERS TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE SIDERAILS WILL NOT STAY UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 | BIRTHING BED | HDD | HILL-ROM INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |