FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE-TREAT SURFACE&SCALE
MDR report key: 1843739
·
Received September 21, 2010
Report
- Report Number
- 1824206-2010-10043
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 25, 2010
- Report Date
- August 25, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH REPLACED THE LEFT USER CONTROL MODULE AND THE POWER CONTROL MODULE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
TECH ALLEGED THAT THE BED HAD NO FUNCTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE-TREAT SURFACE&SCALE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |