FDA Adverse Event
Death
Summary report: N
CARE SENSE BSN-020
MDR report key: 732411
·
Received June 26, 2006
Report
- Report Number
- 1650927-2006-00002
- Event Type
- Death
- Date Received
- June 26, 2006
- Date of Event
- September 11, 2005
- Report Date
- June 22, 2006
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT NOT AVAILABLE FOR EVALUATION. FACILITY NOT IDENTIFIED.
Description of Event or Problem · 1
RESIDENT FELL WHILE BEING MONITORED BY AN BSN-020. MONITOR FAILED TO SIGNAL AN AUDIBLE ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARE SENSE BSN-020 | BED EXIT SENSOR | KMI | NURSE ASSIST, INC. | BSN-020 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Death |