BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEDICS

    MDR report key: 876644 · Received June 11, 2007

    Report

    Report Number
    1832894-2007-00062
    Event Type
    Other
    Date Received
    June 11, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 16, 2007
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Product Code
    DXN
    PMA / PMN Number
    K013539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR TESTING SHOWED THAT THE UNIT IS FUNCTIONING AS DESIGNED. PRODUCT INSTRUCTION BOOKLET STATES: "BLOOD PRESSURE MEASUREMENT CAN BE AFFECTED BY THE POSITION OF THE USER, HIS OR HER PHYSIOLOGIC CONDITION AND OTHER FACTORS. FOR GREATEST ACCURACY, WAIT 1 HOUR AFTER EXERCISING, BATHING, EATING, DRINKING BEVERAGES WITH ALCOHOL OR CAFFEINE, OR SMOKING TO MEASURE BLOOD PRESSURE. BEFORE MEASUREMENT, IT IS SUGGESTED THAT YOU SIT QUIETLY FOR 15 MINUTES, AS MEASUREMENTS TAKEN DURING A RELAXED STATE WILL HAVE GREATER ACCURACY... THE POSITIONING OF THE ARM CUFF IS IMPORTANT IN ORDER TO GET A CORRECT READING." (SEE ADD'L SCANNED PAGES).

    Description of Event or Problem · 1

    CUSTOMER WAS TAKING MEDICINE THAT WARNS IT CAN RAISE BP, USED HOMEDICS BP UNIT BPA-250WGN IN 2007. HE CALLED THE PARAMEDICS BECAUSE HE THOUGHT HE WAS HAVING A HEART ATTACK. PARAMEDICS ARRIVED AND CUSTOMER WAS OKAY, ONLY SCARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEDICS BLOOD PRESSURE MONITOR DXN ROSSMAX INTERNATIONAL LTD. BPA-250WGN

    Patients

    Seq Age Sex Outcome Treatment
    1 YR