BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7 SERIES AUTOMATIC BLOOD PRESSURE MONITOR

    MDR report key: 4600504 · Received March 11, 2015

    Report

    Report Number
    1450057-2015-00002
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    February 27, 2015
    Report Date
    March 2, 2015
    Manufacturer
    OMRON DALIAN CO., LTD
    Product Code
    DXN
    PMA / PMN Number
    K061822
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT OCCURRED IN (B)(6). REPORTING IN THE U.S., DUE TO SIMILAR PRODUCT SOLD IN THE U.S. .

    Description of Event or Problem · 1

    (B)(6) CONSUMER CLAIMS ON (B)(6)2015, FRIDAY MORNING AT APPROXIMATELY 1:30 AM HIS WIFE WORK UP TO A TERRIBLE HEADACHE. CLAIMS SHE TOOK A BP READING WHICH MEASURED 145/97 ON HER HOME BP MONITOR. CLAIMS 30 MINUTES LATER SHE BECAME SO ILL HE CALLED AN EMT SERVICE. CLAIMS SHE WAS TRANSPORTED TO THE EMERGENCY ROOM WHERE HER BP READ 230/115 ON THE HOSPITAL MONITOR(S). CLAIMS SHE WAS IMMEDIATELY GIVEN MEDICATION AND SOLUTIONS BY I.V., TO LOWER HER BP. CLAIMS WITHIN 30 MINUTES HER BP WAS LOWERED TO 197/100. CLAIMS CONTINUED TREATMENT IN THE EMERGENCY ROOM FOR THE NEXT SIX (6) HOURS UNTIL HER BP WAS STABILIZED TO 138/95. CLAIMS SHE WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH A HEART ATTACK. CLAIMS SHE DID NOT HAVE SURGERY AND THE TREATMENT PLAN HAS BEEN BED REST AND MEDICATION TO LOWER AND STABILIZE HER BLOOD PRESSURE. STABILIZE HER BLOOD PRESSURE. CONSUMER CLAIMS THE HOME UNIT HAS READ HIS WIFE'S BP AS LOW SINCE THE DATE OF PURCHASE COMPARED TO READINGS RECEIVED IN THE DOCTOR'S OFFICE. CLAIMS THEY DID NOT RETURN THE UNIT TO THE PLACE OF PURCHASE BECAUSE HIS WIFE NEEDED TO MONITOR HER BP DAILY ON THE ADVICE OF HER MD CLAIMS HIS WIFE MONITORS HER BP 2-3 TIMES PER DAY. HOWEVER, THE CONSUMER CLAIMS THE MONITOR PROVIDES ACCURATE READINGS ON HIM AND THAT IS ANOTHER REASON THEY DID NOT RETURN THE UNIT TO THE RETAILER OR MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169576 7 SERIES AUTOMATIC BLOOD PRESSURE MONITOR 7 SERIES AUTOMATIC BP MONITOR DXN OMRON DALIAN CO., LTD BP760CAN 20110801078LG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R