FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE-
MDR report key: 2151345
·
Received June 7, 2011
Report
- Report Number
- 1824206-2011-03101
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT HAS NOT RETURNED HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.
Description of Event or Problem · 1
COMPLAINT ALLEGED THAT THE HEAD HI/LOW WILL NOT LOWER ELECTRICALLY OR WITH TREND PEDAL. NO INJURY ALLEGED.
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 |