FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2143514
·
Received June 2, 2011
Report
- Report Number
- 1824206-2011-03058
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- May 4, 2011
- Report Date
- May 4, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNTS ENGINEER STATED THE LOCAL ALARM FOR BED EXIT IS NOT SOUNDING BUT IT WORKS FOR OTHER THINGS. HE HAS REPLACED THE POWER CONTROL MODULE BUT THE ISSUE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |