FDA Adverse Event
Other
Summary report: N
TOTALCARE BED
MDR report key: 1652237
·
Received March 29, 2010
Report
- Report Number
- 1824206-2010-04868
- Event Type
- Other
- Date Received
- March 29, 2010
- Date of Event
- March 4, 2010
- Report Date
- March 5, 2010
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY'S MAINTENANCE DEPARTMENT TESTED THE ALARM AND FOUND IT WORKING PROPERLY. THE TECHNICIAN STATED, THE ACCOUNT WOULD NOT PROVIDE A SERIAL NUMBER AND WOULD NOT MAKE THE BED AVAILABLE FOR INSPECTION.
Description of Event or Problem · 1
THE ACCOUNTS CHARGE NURSE ALLEGED THE PT CLIMBED OUT OF BED AND FELL CAUSING HEAD INJURIES. THE BED EXIT WAS ARMED AND FUNCTIONAL BUT THE VOLUME WAS TURNED OFF AND THE BED WAS NOT PLUGGED INTO THE NURSE CALL SYSTEM. THE ACCOUNT STATED, THE PT'S INJURY WAS BLEEDING OF THE BRAIN. NO TREATMENT INFO WAS PROVIDED BY THE ACCOUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM RITTER | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |