FDA Adverse Event
Malfunction
Summary report: N
AFFINITY IV BED
MDR report key: 2920267
·
Received December 17, 2012
Report
- Report Number
- 1824206-2012-08235
- Event Type
- Malfunction
- Date Received
- December 17, 2012
- Date of Event
- April 23, 2012
- Report Date
- November 7, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN INVESTIGATED THE ALLEGED COMPLAINT AND THE FACILITY COULD NEVER LOCATE THE BED. THE TECHNICIAN AND THE ACCOUNT INSPECTED EVERY BED AND THE BED COULD NOT BE LOCATED. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE BRAKES WERE DISCOVERED TO FAIL AND THEY ARE IN THE PROCESS OF HAVING THE BRAKES REPLACED FOR A SECOND TIME. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY IV BED | BIRTHING BED | HDD | HILL-ROM INC. | 3700 | H334AA4806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |