FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE-
MDR report key: 2170798
·
Received June 22, 2011
Report
- Report Number
- 1824206-2011-03379
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND BED IN ICU STORAGE AREA. THE LEFT SIDERAIL CONTROLS ARE NOT WORKING. THE SERVICE REQUIRED LED IS FLASHING. FOUND: FLUID LEAKED ON THE LEFT CAREGIVER PC BOARD. REPLACED THE LEFT CAREGIVER PC BOARD TO RESOLVE ISSUE.
Description of Event or Problem · 1
FACILITY ALLEGED THAT THE LEFT SIDERAIL CONTROLS WERE NOT WORKING. NO ALLEGED INJURIES REPORTED BY THE ACCOUNT.
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 |