FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2881270
·
Received November 14, 2012
Report
- Report Number
- 1824206-2012-07453
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Date of Event
- October 25, 2012
- Report Date
- October 25, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
HILL-ROM TECH FOUND THAT THERE WAS FLUID INGRESS ON THE RIGHT UCM BOARD. HE FOUND THAT THE SIDERAIL LABEL HAD BEEN TORN. HE DID NOT KNOW WHAT HAD TORN THE LABEL OR HOW IT HAD GOTTEN TORN. HE REPLACED THE RIGHT UCM BOARD AND RIGHT CAREGIVER LABEL AND THE BED FUNCTIONED TO SPECIFICATIONS.
Description of Event or Problem · 1
INFO RECEIVED INDICATED THE CHAIR FUNCTION FROM RIGHT INTERMEDIATE SIDERAIL DID NOT OPERATE.
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 |