BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOVAC ELITE V2.0

    MDR report key: 5004152 · Received August 12, 2015

    Report

    Report Number
    2435501-2015-00001
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 15, 2015
    Report Date
    August 7, 2015
    Manufacturer
    IT SYNERGISTICS, LLC
    Product Code
    MMH
    PMA / PMN Number
    BK140091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFER TO ATTACHED REPORT FOR INVESTIGATION AND CORRECTIVE ACTION.

    Description of Event or Problem · 1

    THE DOVAC ELITE V2.0 SYSTEM ALLOWED THE TECHNICIAN REVIEW PROCESS TO BE COMPLETED FOR A FULL LENGTH DONOR HISTORY QUESTIONNAIRE (DHQ) WITHOUT OBTAINING A RESPONSE FOR A SINGLE QUESTION. REFER TO THE ATTACHED REPORT BEGINNING ON PAGE 4 FOR A COMPLETE INVESTIGATION AND CORRECTIVE ACTION COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530338 DOVAC ELITE V2.0 DOVAC ELITE V2.0 MMH IT SYNERGISTICS, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1