FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE SPO2RT
MDR report key: 1904054
·
Received November 12, 2010
Report
- Report Number
- 1824206-2010-10969
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 18, 2010
- 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
REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE HEAD OF THE BED IS DRIFTING SLOWLY AND STAYING IN TRENDELENBURG.
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 |