FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2142607
·
Received June 21, 2011
Report
- Report Number
- 1824206-2011-03355
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THREE ATTEMPTS HAVE BEEN MADE TO GET ADDITIONAL INFORMATION ON THIS ALLEGED COMPLAINT. THE ACCOUNT HAS NOT BEEN RETURNED. HILL-ROM'S ATTEMPTS TO DETERMINE THE RESOLUTION OF THE ALLEGED MALFUNCTION.
Description of Event or Problem · 1
COMPLAINT RECEIVED INDICATING THAT THE HEAD HI/LOW DRIFTS DOWN VERY SLOWLY ON THE BED. NO INJURY REPORTED.
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 |