FDA Adverse Event
Injury
Summary report: N
CARESENSE BSN - 045
MDR report key: 1368183
·
Received January 23, 2009
Report
- Report Number
- 1650927-2009-00001
- Event Type
- Injury
- Date Received
- January 23, 2009
- Date of Event
- January 6, 2009
- Report Date
- January 22, 2009
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE CONDUCTED A FULL FUNCTIONAL TEST ON THE MONITOR AND SENSOR PAD. THE MONITOR AND SENSOR PAD WERE FULLY FUNCTIONAL, THERE WAS EVIDENCE OF SIGNIFICANT ABUSE TO SENSOR PAD AND MONITOR. THE DISTRIBUTOR WAS CAUTIONED TO INSTRUCT THE CAREGIVER ON THE PROPER CARE, AND MAINTENANCE OF THIS PRODUCT.
Description of Event or Problem · 1
MONITOR HAD A DELAYED RESPONSE TO THE CAREGIVER. RESIDENT FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARESENSE BSN - 045 | CHAIR SENSOR PAD MONITOR | KMI | NURSE ASSIST, INC. | BSN-045 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Hospitalization |