FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 2253837
·
Received August 11, 2011
Report
- Report Number
- 1824206-2011-04263
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 1, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE 37 PIN CONNECTOR WAS BROKEN ON THE UTV RELAY J-BOX CIRCUIT BOARD. THE TECHNICIAN REPLACED THE J-BOX CIRCUIT BOARD TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE BED IS NOT SENDING A NURSE CALL TO THE NURSES' STATION.
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 |