BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIBER OPTIC RECEPT.REPLAC

    MDR report key: 522567 · Received February 11, 2004

    Report

    Report Number
    2023988-2004-00016
    Event Type
    Malfunction
    Date Received
    February 11, 2004
    Report Date
    February 11, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALTHOUGH THE CUSTOMER ATTACHED A NEW NL950-FR, THE MONITOR DISPLAYED "E08" AND ZERO BALANCING WAS IMPOSSIBLE. REPLACING IT WITH ANOTHER FIBER OPTIC RECEPTACLE SOLVED THE TROUBLE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIBER OPTIC RECEPT.REPLAC NEURO MONITORING GWM INTEGRA NEUROCARE LLC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *