FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BARIATRIC BED
MDR report key: 2050828
·
Received April 4, 2011
Report
- Report Number
- 1824206-2011-01997
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 10, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THERE WAS A BLANKET BETWEEN THE SIDE RAIL AND THE MATTRESS PREVENTING THE SIDE RAIL FROM LOCKING IN THE UPRIGHT POSITION. THE TECHNICIAN REMOVED THE BLANKET TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
ACCOUNT ALLEGED THAT THE RIGHT SIDE RAIL DOES NOT STAY IN THE UPRIGHT POSITION. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL CARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |