FDA Adverse Event
Malfunction
Summary report: N
AFFINITY BED
MDR report key: 1870520
·
Received October 6, 2010
Report
- Report Number
- 1824206-2010-10327
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- September 13, 2010
- Report Date
- September 13, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE HI/LOW DRIVE TO RESOLVE THE DRIFTING ISSUE. HE FOUND THE BED OUT OF SERVICE IN THE BED SHOP AND THERE WERE NO INJURIES.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES, THE HI/LOW DRIVE IS DRIFTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |