FDA Adverse Event
Malfunction
Summary report: N
CARESENSE BSN-010
MDR report key: 1377722
·
Received March 9, 2009
Report
- Report Number
- 1650927-2009-00002
- Event Type
- Malfunction
- Date Received
- March 9, 2009
- Date of Event
- February 9, 2009
- Report Date
- March 6, 2009
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MONITOR FAILED TO SIGNAL AN AUDIBLE ALARM. WE CONDUCTED A FULL FUNCTIONAL TEST ON THE MONITOR. THE MONITOR FUNCTIONED PROPERLY EXCEPT THE AUDIBLE ALARM SIGNALED FOR A SHORT TIME THEN STOPPED. THE ALARM WAS REPLACED AND FUNCTIONED PROPERLY. NO ROOT CAUSE WAS DETERMINED FOR THE AUDIBLE ALARM FAILURE. THE DISTRIBUTOR WAS CAUTIONED TO INSTRUCT THE CAREGIVER ON THE PROPER CARE AND TESTING OF THE PRODUCT PRIOR TO USE.
Description of Event or Problem · 1
RESIDENT FELL WHILE BEING MONITORED BY A BSN-010 MONITOR. MONITOR FAILURE TO SIGNAL AN AUDIBLE ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARESENSE BSN-010 | BED EXIT MONITOR | KMI | NURSE ASSIST, INC. | BSN-010 | 758IE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization |