BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITERION V100 BGM TELEHEALTH SYSTEM

    MDR report key: 3253559 · Received June 17, 2013

    Report

    Report Number
    3003962513-2013-00002
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    VITERION CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K030419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), A CUSTOMER FROM (B)(6), REPORTED THAT VISNET WAS REPORTING A PULSE READING OF 0 'ZERO.' A COMPLETE BLOOD PRESSURE MONITOR WAS REPLACED AND STILL RECEIVING RANDOM READINGS OF 0 FOR PULSE. PT = CRM, LAST4 = 5167, V100 SN = (B)(4). CUSTOMER HAS CONFIRMED WITH PATIENT, WHEN METER PULSE READING IS BELOW 35 THE PATIENT RECEIVES ERR ON THE METER AND 0 READING ON THE V100 MONITOR. CURRENT V100 BGM DOES NOT ALLOW PASSING UP OF ERR READING TO VISNET. ERR MEANS CUFF NEEDS TO BE ADJUSTED PER A AND D DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274621 VITERION V100 BGM TELEHEALTH SYSTEM TELEHEALTH MONITOR, PRODUCT CODE: MWI MWI VITERION CORPORATION V100-BGM

    Patients

    Seq Age Sex Outcome Treatment
    1