FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC PLUS
MDR report key: 1993239
·
Received January 21, 2011
Report
- Report Number
- 1824206-2011-00382
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- April 1, 2008
- Report Date
- April 1, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN HAS REPLACED THE VALVES AND THE EMERGENCY TRENDELENBURG VALVE BUT THE ISSUE REMAINS. TECHNICAL SUPPORT TOLD TECHNICIAN TO TRY REPLACING THE CYLINDER. NO FURTHER INFORMATION IS AVAILABLE ON THIS REPAIR. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE HEAD HI/LOW IS DRIFTING. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC PLUS | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |