BEUDAMED
    FDA Adverse Event Other Summary report: N

    SENSATEC

    MDR report key: 672276 · Received February 1, 2006

    Report

    Report Number
    2134311-2006-00002
    Event Type
    Other
    Date Received
    February 1, 2006
    Date of Event
    December 31, 2005
    Report Date
    January 20, 2006
    Manufacturer
    R.F. TECHNOLOGIES, INC.
    Product Code
    KMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THAT PATIENT WAS USING A CONTROLLER AND PAD. UNIT WAS ROUTINELY TESTED BY STAFF BEFORE PATIENT USE. PATIENT TRIED TO GET UP AND FELL. REPORT ALLEGED ALARM DID NOT SOUND. PATIENT HAD BEEN CALLING NURSES EVERY 3-4 MINUTES SO WHEN THEY HADN'T HEARD FROM HIM IN 11 MINUTES, THEY WENT TO CHECK AND FOUND HIM ON THE FLOOR. PATIENT WAS HYPOXIC (HE MIGHT HAVE BEEN THIS WAY BEFORE THE FALL) UNRESPONSIVE AND CYANOTIC. HE WAS TAKEN TO THE ER, BUT REGAINED CONSCIOUSNESS ON THE WAY THERE. FACILITY REPORTS HIS TRACH HAD BEEN DISPLAYED AND HIS G-TUBE HAD CAUSED SOME TRAUMA TO THE ABDOMINAL WALL. ACCORDING TO THE FACILITY THESE PROBLEMS WERE RESOLVED BY THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSATEC BED-CHAIR MONITOR KMI R.F. TECHNOLOGIES, INC. ST-320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization