BEUDAMED
    FDA Adverse Event Death Summary report: N

    CODE ALERT

    MDR report key: 383046 · Received March 15, 2002

    Report

    Report Number
    2134311-2002-00001
    Event Type
    Death
    Date Received
    March 15, 2002
    Date of Event
    February 12, 2002
    Report Date
    February 13, 2002
    Manufacturer
    RF TECHNOLOGIES, INC.
    Product Code
    KMI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY FACILITY, "RESIDENT FOUND WITH THEIR HEAD BETWEEN THE BED AND THE RAIL. PT'S LOWER BODY WAS OFF THE BED. THE RESIDENT WAS NOT BREATHING AND NO VITAL SIGNS. THE BED ALARM DID NOT SOUND. UPON FURTHER INVESTIGATION THE WIRE CONNECTING THE SENSOR PAD TO THE SENSOR ALARM WAS BROKEN. SENSOR BOX CONTINUED TO SHOW IT WAS FUNCTIONING PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODE ALERT BED ALARM KMI RF TECHNOLOGIES, INC. SENSOTEC ST 400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death