BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3911905

    MDR report key: 3911905 · Received June 30, 2014

    Report

    Report Number
    3911905
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 30, 2014
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE WIRE WOULD NEVER GIVE A READING. PRESSURE WIRE WAS PROPERLY FLUSHED, ZEROED AND EQUALIZED. WIRE WAS USED FOR MEASUREMENTS, THEN LEFT IN THE VESSEL FOR INTERVENTION. POST INTERVENTION THE WIRE WAS RECONNECTED AND AN ATTEMPT TO RE-MEASURE FAILED AFTER ARTIFACT KEPT SHOWING ON THE MONITORS.

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR