FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2220549
·
Received July 18, 2011
Report
- Report Number
- 1824206-2011-03762
- Event Type
- Malfunction
- Date Received
- July 18, 2011
- Date of Event
- June 28, 2011
- Report Date
- June 28, 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 INSPECTED THE BED AND FOUND FLUID HAD GOTTEN INSIDE THE LEFT INTERMEDIATE SIDERAIL AND DAMAGED THE CAREGIVER PC BOARD. REPLACED THE LEFT CAREGIVER PC BOARD TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
FACILITY COMPLAINT IS THAT THE LEFT INTERMEDIATE SIDERAIL "SERVICE REQUIRED" LED IS ILLUMINATED. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |