FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 2883540
·
Received November 15, 2012
Report
- Report Number
- 1824206-2012-07481
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 25, 2012
- Report Date
- October 25, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN REPLACED THE HEAD HI-LO CYLINDER TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATED THE HEAD HI-LO DRIFTS DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |