BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOMEDICS

    MDR report key: 876640 · Received June 11, 2007

    Report

    Report Number
    1832894-2007-00067
    Event Type
    Other
    Date Received
    June 11, 2007
    Date of Event
    December 7, 2006
    Report Date
    January 25, 2007
    Manufacturer
    ROSSMAX INTERNATIONAL LTD.
    Product Code
    DXN
    PMA / PMN Number
    K013539
    Adverse Event
    Yes
    Product Problem
    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. "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 HR AFTER EXERCIZING, 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 MINS, AS MEASUREMENTS TAKEN DURING A RELAXED STATE WILL HAVE GREATER ACCURACY...THE POSITIONING OF THE ARM CUFF IS IMPORTANT TIN ORDER TO GET A CORONARY READING." SEE ADD'L SCANNED PAGES.

    Description of Event or Problem · 1

    BP MONITOR READING HIGH. DR ADJUSTED HYPERTENSION MEDICATION BASED ON READINGS. SUBSEQUENTLY DR SUSPECTED THE READINGS WERE HIGH AND COMPARED BP MONITOR TO HIS OWN EQUIPMENT.

    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