FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 2142583
·
Received June 21, 2011
Report
- Report Number
- 1824206-2011-03371
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 2, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE SIDERAIL LATCH GUARD AND TESTED, SIDERAIL FUNCTIONED PROPERLY.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THE LEFT INTERMEDIATE SIDERAIL LATCH GUARD WAS BADLY BENT, RESTRICTING THE SIDERAIL FROM BEING PLACED IN RAISED POSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |