BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED BLOOD PRESSURE MONITOR WITH ARM CUFF

    MDR report key: 1982669 · Received December 14, 2010

    Report

    Report Number
    1450057-2010-00005
    Event Type
    Injury
    Date Received
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    OMRON (DALIAN) CO., LTD. (PLANT 1)
    Product Code
    DXN
    PMA / PMN Number
    K052154
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CLAIMS ON APPROX (B)(6) 2008, HER DOCTOR PRESCRIBED AND ORDERED HER A HOME BP MONITOR. CUSTOMER CLAIMS DUE TO A HISTORY OF EXTREMELY HIGH BP, HER MD ORDERS WERE TO TAKE A READING 2-3 TIMES PER DAY AND PHONE IN THE READINGS. CUSTOMER CLAIMS MD WOULD THEN ADJUST HER MEDICATION BASED ON THE MONITOR'S BP READINGS. CUSTOMER CLAIMS FOR THE LAST SEVERAL MONTHS, THE UNIT WOULD GIVE AN ERROR MESSAGE AND NOT PROVIDE A READING. CUSTOMER STATES SHE WOULD THEN TAKE MULTIPLE BACK-TO-BACK READINGS UNTIL A VALUE WAS PROVIDED ON THE HOME MONITOR. CUSTOMER ALSO STATED SHE WOULD WRAP THE CUFF VERY TIGHTLY TO THE POINT OF PAIN TO ASSURE A TIGHT FIT IN AN ATTEMPT TO GET A READING ON THE FIRST TRY. CUSTOMER CLAIMS HER MD DID NOT HAVE HER COME INTO THE OFFICE TO TAKE A PROFESSIONAL READING ON THE OFFICE EQUIPMENT PRIOR TO ADJUSTING HER MEDICATION. CUSTOMER STATES NO COMPARISON READINGS DONE WITH HER HOME UNIT ON ROUTINE VISITS TO THE DOCTOR'S OFFICE. CUSTOMER STATES THE BP CUFF IS ORIGINAL TO THE UNIT. THE CONSUMER HAS NOT RETURNED TO UNIT FOR INSPECTION TO DATE. IF THE CUSTOMER PROVIDES THE UNIT FOR INSPECTION, A FOLLOW UP REPORT WILL BE SUBMITTED. ERROR MESSAGE INDICATORS ARE: EE - CUFF EITHER OVER OR UNDER-INFLATED. CUFF NOT APPLIED CORRECTLY. MONITOR COULD NOT DETECT PULSE WAVE. AIR PLUG IS NOT CONNECTED. CORRECTION - REMOVE THE ARM CUFF. READ "TAKING A MEASUREMENT." REAPPLY CUFF AND TAKE ANOTHER MEASUREMENT. REMAIN STILL UNTIL THE MEASUREMENT IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS READING 30 TO 40 POINTS HIGH WHEN COMPARED TO DOCTOR. CUSTOMER STATES UNIT WAS SHOWING IN THE 180 OR OVER 200. CUSTOMER STATES HER NORMAL PRESSURE IS 120/80 OR LESS. CUSTOMER CLAIMS SHE WAS BEING TREATED FOR EXTREME HIGH BLOOD PRESSURE BY HER DOCTOR ACCORDING TO HER READINGS ON HER UNIT. CUSTOMER STATES BECAUSE OF THE MEDICINE SHE WAS GIVEN, SHE CRASHED HER CAR AND BLACKED OUT. CUSTOMER STATES THAT WHEN SHE CRASHED HER CAR, SHE WAS BEING OVER TREATED WITH MEDICINE BY HER DOCTOR AND HER BLOOD PRESSURE BOTTOMED OUT BECAUSE OF HER UNIT. CUSTOMER WAS TREATED BY AMBULANCE AND WAS IN THE HOSPITAL FOR SIX DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED BLOOD PRESSURE MONITOR WITH ARM CUFF AUTOMATED BLOOD PRESSURE MONITOR DXN OMRON (DALIAN) CO., LTD. (PLANT 1) HEM-711AC 20080514819LF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization