BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5056808

    MDR report key: 5127416 · Received September 29, 2015

    Report

    Report Number
    MW5056808
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 29, 2015
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH A HEARTWARE HVAD CAME TO CLINIC AS A PLANNED VISIT. DURING THE INTERROGATION OF HER HEARTWARE HVAD IT WAS NOTED THE POWER CONNECTOR PORT #2 ON CONTROLLER # CON097932 WAS LOOSE-PULLING AWAY FROM THE CONTROLLER. THE CONTROLLER WAS REPLACED WITH CON 098487 WITHOUT INCIDENT. THE HEARTWARE CLINICAL REP WAS NOTIFIED.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention