FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BARIATRIC BED
MDR report key: 2050165
·
Received April 5, 2011
Report
- Report Number
- 1824206-2011-02014
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 13, 2011
- Report Date
- March 13, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT FOUND THE HEAD UP VALVE WAS STUCK. THE ACCOUNT REPLACED THE HEAD UP VALVE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
ACCOUNT ALLEGED NO HEAD UP. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL CARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |