BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATIC BLOOD PRESSURE MONITOR

    MDR report key: 5038574 · Received August 24, 2015

    Report

    Report Number
    MW5055803
    Event Type
    Injury
    Date Received
    August 24, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    OMRON HEALTHCARE, INC.
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM A (B)(6) YEAR OLD MALE AND TAKE PRESCRIPTION BLOOD PRESSURE MEDICATION DAILY. I AM ALSO A STROKE SURVIVOR FROM A MAJOR STOKE IN 2009 DUE TO BLUNT FORCE TRAUMA; NOT A FLOW ISSUE. TODAY AT 9:15 AM I WAS CHECKING MY BLOOD PRESSURE. I USE AN OMRON BP791IT (HEM-7222-ITZ) MONITOR. IT IS SET TO TAKE MY BLOOD PRESSURE VIA THREE COMPUTERIZED MEASUREMENTS AND AVERAGE. TODAY, IT TOOK THE FIRST READING AND THEN DEFLATED THE CUFF AND RESTARTED AFTER 30 SECONDS. THAT IS NORMAL. THE SECOND READING BEGAN AND WAS OBTAINED AND THE MACHINE STOPPED AS USUAL. THEN AFTER 5 SECONDS WHILE THE CUFF WAS STILL FULLY INFLATED THE MACHINE TURNED ITSELF ON AGAIN AND BEGAN INFLATING THE CUFF WHICH WAS ALREADY FULLY INFLATED. I KIND OF FROZE AS I WAS STARTLED AND IN SHOCK AS THE PRESSURE KEPT INCREASING SUCH THAT IT WAS APPROACHING 275 ON THE MONITOR. AT THAT POINT MY ARM MUSCLE WAS IN PAIN AND IT SNAPPED ME OUT OF MY TRANCE SO I RIPPED THE CUFF OFF FROM MY ARM YET THE MACHINE CONTINUED TO INFLATE THE CUFF FOR ANOTHER (APPROXIMATELY) TEN SECONDS UNTIL IT REPORTED A READING ERROR CODE (E5) WHILE THE CUFF RESTED ON THE TABLE. THE E5 CODE MEANS THAT CLOTHING INTERFERED WITH THE READING AND THE MACHINE STOPPED. I WAS NOT WEARING ANY CLOTHING (SHIRT) TODAY NEAR THE ARM AND I USE THIS MACHINE DAILY AND THE MACHINE STOPPED WHILE NOTHING WAS INSERTED INSIDE THE CUFF EXCEPT AIR. I AM IN PRETTY GOOD SHAPE AS THE BLOOD PRESSURE ISSUE IS RELATED TO A TIGHTENED LUNG AS A RESULT OF ASTHMA. HOWEVER, I DID 75 ARM CURLS YESTERDAY WITH A 10 POUND DEAD WEIGHT SO MY MUSCLE WAS TIGHT TODAY. POSSIBLY THAT CONFUSED THE MACHINE? IF I WAS OLDER THAT MACHINE WOULD HAVE PHYSICALLY HURT SOMEONE. I AM LUCKY I SNAPPED OUT OF MY SHOCK TO WHAT WAS HAPPENING AND TORE THE CUFF OFF MY ARM. I WAS ACTUALLY MESMERIZED THAT THE MACHINE TURNED ITSELF BACK ON AS I WATCHED THE UPPER BLOOD PRESSURE NUMBER ON THE MONITOR APPROACH 275. THIS MACHINE IS FROM HELL AND YOU NEED TO REALLY LOOK INTO IT. WE PURCHASED IT IN (B)(6) 2013. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559430 AUTOMATIC BLOOD PRESSURE MONITOR AUTOMATIC BLOOD PRESSURE MONITOR DXN OMRON HEALTHCARE, INC. BP791IT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention