FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2933365
·
Received December 21, 2012
Report
- Report Number
- 1824206-2012-08452
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 6, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN STATED HE THOUGHT "SOMETHING WAS SPILLED ONTO SIDERAIL" CAUSING THE BLUE STRIPE. HE REPLACED THE GCI TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATED THERE WAS A ONE INCH BLUE STRIPE RUNNING HORIZONTALLY THROUGH CENTER OF THE GRAPHICAL CAREGIVER INTERFACE (GCI).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |