FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE SPO2RT
MDR report key: 2112774
·
Received April 29, 2011
Report
- Report Number
- 1824206-2011-02465
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 6, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE VALVE GUIDE TUBE WAS NOT FUNCTIONING. HE REPLACED THE VALVE GUIDE TUBE TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION REC'D INDICATES THE HEAD HI/LOW FUNCTION IS DRIFTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE SPO2RT | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |