FDA Adverse Event
Death
Summary report: N
SENSATEC
MDR report key: 820507
·
Received February 7, 2007
Report
- Report Number
- 2134311-2007-00001
- Event Type
- Death
- Date Received
- February 7, 2007
- Report Date
- January 30, 2007
- Manufacturer
- RF TECHNOLOGIES, INC
- Product Code
- KMI
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
Narratives
Additional Manufacturer Narrative · 1
MFG INVESTIGATION OF ADVERSE EVENT DETERMINED SUSPECT DEVICE MIGHT HAVE FAILED TO ALARM AT THE REMOTE NURSE STATION DUE TO THE LOW POWER CONDITION ON THE 9 V DC BATTERY AND/OR THE IMPROPER AC ADAPTER COMPONENT BEING USED WITH SUSPECT UNIT. POST EVENT TEST OF THE FAILED UNIT CONFIRMS THESE RESULTS SINCE THE LOW BATTERY CONDITION WAS PRESENT AND THE UNIT WAS ALARMING A LOW BATTERY CONDITION AS SPECIFIED BY THE MFG. FACILITY WAS NOTIFIED OF MFG INVESTIGATION RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSATEC | BED PT MONITOR | KMI | RF TECHNOLOGIES, INC | ST 400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |