BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN PRECISIONSENSOR

    MDR report key: 533948 · Received July 7, 2004

    Report

    Report Number
    9617642-2004-00003
    Event Type
    Other
    Date Received
    July 7, 2004
    Report Date
    July 7, 2004
    Manufacturer
    BRAUN GMBH
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN JUNE, 2004, THE CONSUMER CONTACTED BRAUN CONSUMER SERVICE VIA THE TOLL FREE NUMBER AND REPORTED THAT THE BRAUN BLOOD PRESSURE MONITOR READ 10-18 POINTS LOW FOR SYSTOLIC AND 12 FOR DIASTOLIC. CONSUMER REPORTED MONITORING THEIR BLOOD PRESSURE BECAUSE IF BLOOD PRESSURE GETS HIGH CONSUMER HAS TO TAKE MEDICATION TO CONTROL IT. CONSUMER REPORTED THAT BLOOD PRESSURE MONITOR WAS GIVING LOW READINGS AND CUSTOMER THOUGHT BLOOD PRESSURE WAS UNDER CONTROL AND DID NOT TAKE MEDICATION. CONSUMER HAD STROKE AT WORK BECAUSE THEIR BLOOD PRESSURE WAS 10-18 POINTS HIGHER THAN BRAUN BLOOD PRESSURE MONITOR. CONSUMER DID NOT PROVIDE READINGS THAT WERE OBTAINED BECAUSE ALL CONSUMER WANTS IS THEIR MONEY BACK. CONSUMER WAS TAKEN TO ER AND WAS GIVEN MEDICATION TO CONTROL HIGH BLOOD PRESSURE. IN 2004 THE CONSUMER PROVIDED THE FOLLOWING INFO ABOUT THE INCIDENT WHICH CONSUMER REPORTED TO THE CO IN 2004: CONSUMER COULD NOT REMBEMBER DATE THAT INCIDENT OCCURRED, CONSUMER WAS HOSPITALIZED FOR THREE DAYS, THERE WAS NO PERMANENT DAMAGE FROM THE INCIDENT, THE HOSP CHECKED HEART CATH AND TEST RESULTS WERE OKAY, AND CAROTID STUDY RESULTS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAUN PRECISIONSENSOR WRIST BLOOD PRESSURE MONITOR DXN BRAUN GMBH BP2550 3107

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R