BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL MEDICAL PRODUCTS PERSONAL SENTRY

    MDR report key: 2196164 · Received January 7, 2011

    Report

    Report Number
    1929691-2010-00004
    Event Type
    Other
    Date Received
    January 7, 2011
    Date of Event
    November 3, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STANLEY SECURITY SOLUTIONS, INC, SENIOR TECHNOLOGIES DIV
    Product Code
    KMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. THE EQUIPMENT WAS RETURNED BY (B)(6) AND WAS FULLY EVALUATED. THE UMP PERSONAL SENTRY ALARM MODEL # 91230 TESTED ACCORDING TO MFR SPECS. HOWEVER, THE 9V BATTERY THAT WAS RETURNED IN THE UNIT ONLY TESTED AT 5.73 V. DUE TO THE LOW BATTERY VOLTAGE, THE MONITOR'S LOW BATTERY LED PROPERLY FLASHED RED INDICATING THAT THE BATTERY SHOULD BE REPLACED. DURING THE VISUAL EVAL, IT WAS ALSO NOTED THAT THE BATTERY LID TAB WAS BENT DOWNWARD OR DAMAGED BY CUSTOMER THUS NOT ALLOWING FOR THE BATTERY LID TO PROPERLY SECURE TO PERSONAL SENTRY MONITOR.

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: ELDERLY FEMALE PT FOUND DOWN ON LEFT SIDE PERSONAL BELONGINGS BAG UNDER HEAD. PT LIFTED TO BED, SLOW TO RESPOND VERBALLY, NOTED RED AREA ON LEFT TEMPORAL AREA. EYES REACTIVE, GRIPS WEAK, NO OTHER SIGN OF ACUTE INJURY/TRAUMA. PERSONAL ALARM IN PLACE AND NOTED TO SOUND REPEATEDLY THROUGH NIGHT. WHEN PT FOUND IMMEDIATELY AFTER FALL PERSONAL ALARM ON FLOOR AND NOT SOUNDING, NOT FUNCTIONING. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL MEDICAL PRODUCTS PERSONAL SENTRY UMP PERSONAL SENTRY ALARM KMI STANLEY SECURITY SOLUTIONS, INC, SENIOR TECHNOLOGIES DIV 91230 00809

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR