FDA Adverse Event
Malfunction
Summary report: N
UMP
MDR report key: 3225946
·
Received June 25, 2013
Report
- Report Number
- 3225946
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 25, 2013
- Manufacturer
- STANLEY SECURITY SOLUTIONS, INC.
- Product Code
- KMI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
CHAIR ALARM SENSOR WAS DEFECTIVE. PATIENT GOT UP FROM CHAIR AND THE ALARM DID NOT SOUND UNTIL THE PATIENT WAS MORE THAN HALF WAY INTO THE BATHROOM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 287208 | UMP | MONITOR, BED | KMI | STANLEY SECURITY SOLUTIONS, INC. | 91621 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |