FDA Adverse Event
Malfunction
Summary report: N
RN+ FALL WATCH SYSTEM
MDR report key: 1632517
·
Received February 4, 2010
Report
- Report Number
- 1650927-2010-00001
- Event Type
- Malfunction
- Date Received
- February 4, 2010
- Date of Event
- November 13, 2009
- Report Date
- February 23, 2010
- Manufacturer
- NURSE ASSIST, INC.
- Product Code
- KMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUR REP (B)(4) VISITED THE FACILITY ON (B)(4) 2010. HE FOUND THE CONSOLE UNIT NOT PROGRAMMED PROPERLY AND SIGNAL UNITS NOT CHARGED PROPERLY. HE ALSO CONDUCTED A TRAINING SESSION FOR ASSOCIATED PERSONNEL. ALL PRODUCTS WERE FUNCTIONING PROPERLY WHEN HE LEFT THE FACILITY.
Description of Event or Problem · 1
BED ALARM UNIT SOUNDED IN THE PT'S ROOM BUT NOT AT THE NURSE'S STATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RN+ FALL WATCH SYSTEM | BED EXIT MONITOR | KMI | NURSE ASSIST, INC. | BPS-10RF | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |