FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2050153
·
Received April 5, 2011
Report
- Report Number
- 1824206-2011-02019
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND AFTER TROUBLESHOOTING THAT THE PROBLEM IS A FAULTY EMERGENCY TRENDELENBURG VALVE. THE TECHNICIAN REPLACED THE EMERGENCY TRENDELENBURG VALVE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE HEAD HI/LOW DRIFTS DOWN SLOWLY. NO PT IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |