BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRIX TRUE TECH

    MDR report key: 528033 · Received January 22, 2004

    Report

    Report Number
    2023988-2004-00014
    Event Type
    Malfunction
    Date Received
    January 22, 2004
    Date of Event
    December 28, 2003
    Report Date
    January 22, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE EO8 SIGNAL COULD NOT BE CORRECTED. THE CUSTOMER WOULD LIKE TO BE NOTIFIED ON WHAT HAPPENED WITH THE CATHETER. THE FIBEROPTIC CONNECTION TO CABLE WAS NOT CORRECT. THE CATHETER WAS USED ON THE PT WHO PRESENTED TO HOSP IN 2003 DUE TO STROKE. NO VENTRICULOSTOMY WAS PLACED. THE REGIONAL SALES MANAGER ADVISED THE CATHETER BE REMOVED AND REPLACED AND RETURNED FOR EVAL. THEY CONTINUED TO USE WITH THE EO8 SIGNAL. REGIONAL SALES MANAGER UNSURE IF THE CATHETER WAS ZERO BALANCED INCORRECTLY OR IF THE FIBEROPTIC WAS DAMAGED. THE FIBER OPTIC RECEPTACLE AND CABLES WERE REPLACED WITH NO RESOLUTION TO THE EO8 SIGNAL. IT IS UNKNOWN AT THIS TIME IF THE PT EXPIRED. IN 6/2002 THE USER FACILITY PURCHASED FIVE DEVICES LOT NUMBER VTT036A. IN 2/2003 THE LOCAL REP EXCHANGED THE FIVE DUE TO EXPIRATION WITH LOT NUMBER VT0048. THE UNIT HAS TWO VENTRIX MONITORS. THE REGIONAL SALES MANAGER IS ASKING THAT A REVIEW OF THE REPAIR RECORDS FOR THESE MONITORS BE CONDUCTED TO DETERMINE IF THEY HAVE BEEN IN FOR ROUTINE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRIX TRUE TECH NEURO MONITORING GWM INTEGRA NEUROCARE LLC * VTT048

    Patients

    Seq Age Sex Outcome Treatment
    1 *