FDA Adverse Event
Malfunction
Summary report: N
AFFINITY
MDR report key: 1963956
·
Received January 12, 2011
Report
- Report Number
- 1824206-2011-00131
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- August 3, 2006
- Report Date
- August 3, 2006
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE HI/LOW DRIVE TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE HI/LOW IS DRIFTING DOWN ON THIS BED. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AFFINITY | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |