FDA Adverse Event
Malfunction
Summary report: N
AFFINITY 3
MDR report key: 1070835
·
Received July 3, 2008
Report
- Report Number
- 1824206-2008-02793
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 6, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM FIELD INVESTIGATION FOUND THE TREND GAS SPRINGS WOULD NOT ASSIST WHEN THE BED WAS PUT INTO TREND. THE TREND GAS SPRINGS WERE REPLACED TO REPAIR THE BED. UPON COMPLETION OF THE FIELD INVESTIGATION, THE SERVICE TECHNICIAN FOUND THAT NO INJURY OCCURRED. THE FACILITY WAS CONCERNED THAT AN INJURY COULD OCCUR WHEN REMOVING THE BED FROM TREND WITHOUT THE TREND GAS SPRINGS ASSISTING.
Description of Event or Problem · 1
A NURSE INJURED THEIR BACK WHEN ATTEMPTING TO REMOVE THE BED FROM THE TREND POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY 3 | BIRTHING BED | HDD | HILL-ROM RITTER | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |