FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 3190147
·
Received June 10, 2013
Report
- Report Number
- 1824206-2013-03011
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 15, 2013
- Report Date
- May 15, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT FOUND THE CAUSE TO BE THE SOLENOID VALVE. THE ACCOUNT REPLACED THE SOLENOID VALVE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT WHEN THE HEAD DOWN BUTTON IS PRESS AND RELEASED THE HEAD SECTION GOES ALL THE WAY DOWN BY ITSELF. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261962 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |