FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2012024
·
Received February 14, 2011
Report
- Report Number
- 1824206-2011-00833
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- January 31, 2011
- Report Date
- January 31, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE BED HAD "SERVICE REQUIRED" LIGHT AND MULTIPLE CODES. FOUND FLUID INGRESS ON SW3 CAUSED BY PINHOLES FOUND IN LABEL. REPLACED PARTS AND CHECKED FUNCTIONS TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
BED FOUND IN BEDSHOP WITH "SERVICE REQUIRED" LIGHT AND MULTIPLE (B)(4). ORIGIN UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P1900E005242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |