FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1171974
·
Received September 18, 2008
Report
- Report Number
- 1824206-2008-03510
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN WAS PERFORMING PREVENTIVE MAINTENANCE ON THE BIRTHING BED AND FOUND THE HEAD SECTION WOULD DRIFT. THE TECHNICIAN CLEANED THE HEAD DRIVE BRAKE AND REPLACED THE BROKEN SPRING TO REPAIR THE BED. CHAPTER 6 OF THE SERVICE MANUAL DOCUMENTS A FUNCTION CHECK FOR HEAD DRIVE SCREW AS PART OF PREVENTATIVE MAINTANANCE.
Description of Event or Problem · 1
HEAD SECTION FUNCTION OF THE BED IS DRIFTING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM RITTER | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |