FDA Adverse Event
Injury
Summary report: N
CARESENSE BSN-080
MDR report key: 1648977
·
Received April 1, 2010
Report
- Report Number
- 1650927-2010-00002
- Event Type
- Injury
- Date Received
- April 1, 2010
- Date of Event
- February 16, 2010
- Report Date
- March 19, 2010
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE CONDUCTED A FULL FUNCTIONAL TEST ON THE MONITOR AND SENSOR PAD PER THE MANUFACTURING TEST INSTRUCTIONS. THE MONITOR AND SENSOR PAD WERE FULLY FUNCTIONAL. THE UNIT ALARMED PROPERLY WHEN PRESSURE WAS REMOVED FROM THE PAD. THERE WERE NO PROBLEMS FOUND WITH THIS UNIT.
Description of Event or Problem · 1
PATIENT AROSE FROM HER BED, TRIPPED ON THE BED SENSOR CORD ATTACHED TO THE BED ALARM MONITOR, FELL, AND SUFFERED A BROKEN HIP. THE CARE GIVER CLAIMS THAT THE MONITOR DID NOT ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARESENSE BSN-080 | BED EXIT MONITOR | KMI | NURSE ASSIST, INC. | BSN-080 | 662IB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization |