FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 1891339
·
Received November 2, 2010
Report
- Report Number
- 1824206-2010-10795
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 4, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE RENTAL BED WAS REPLACED AT THE ACCOUNT. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE BED EXIT ALARM IS NOT WORKING. THE PATIENT FELL WHILE TRYING TO GET OUT OF BED BY HIM SELF. THE PATIENT IS COMPLAINING OF BACK PAIN. THE DOCTOR SUSPECTS POSSIBLE MUSCULAR/SKELETAL COMPRESSION FRACTURE BUT THE PATIENT IS REFUSING X-RAYS. THE NURSE INDICATED THE PATIENT GETS CONFUSED AND TRIES TO GET UP BY HIMSELF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |