FDA Adverse Event
Malfunction
Summary report: N
CURBELL CARESENSE BSN-010
MDR report key: 832039
·
Received November 2, 2004
Report
- Report Number
- 1650927-2004-00006
- Event Type
- Malfunction
- Date Received
- November 2, 2004
- Report Date
- October 28, 2004
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BSN-010 HAD A COMPONENT THAT WAS CHANGED, PER DCO ON SEPT 2000. NOTIFICATION WILL BE SENT TO ALL CUSTOMERS OF RECORD THAT HAVE MONITORS MANUFACTURED PRIOR TO THIS DCO'S EFFECTIVENESS. THIS COMPONENT CAN BE EASILY REPLACED IN ORDER TO ELIMINATE THE CHANCE OF THIS HAPPENING AGAIN.
Description of Event or Problem · 1
OUR DISTRIBUTOR REPORTED TO ME THAT A BSN-010 HAD CAUSED DAMAGE TO A NURSE CALL SYSTEM. THE UNIT WAS INSPECTED AND FOUND TO BE A PREVIOUS VERSION THAT COULD CAUSE DAMAGE, DUE TO GROUNDING ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURBELL CARESENSE BSN-010 | BED EXIT MONITOR | KMI | NURSE ASSIST, INC. | BSN-010 | 1586 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |