BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBEE 32

    MDR report key: 459628 · Received May 5, 2003

    Report

    Report Number
    9612330-2003-00003
    Event Type
    Malfunction
    Date Received
    May 5, 2003
    Date of Event
    April 3, 2003
    Report Date
    May 3, 2003
    Manufacturer
    EXCEL TECH. LTD.
    Product Code
    GWQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ECOG (ELECTRO-CORTICOGRAPHY), THE EEG MONITORING HEADBOX FAILED TO DISPLAY WAVEFORMS. A SECOND HEADBOX WAS IMMEDIATELY CONNECTED TO REPLACE THE FIRST ONE BUT WAS NOT CONNECTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE WHICH CAUSED THE RECONNECTION FAILURE OF THE REPLACEMENT UNIT. THE SURGEON DECIDED TO PERFORM THE SURGERY WITHOUT EEG MONITORING. ACCORDING TO THE HEAD EEG TECHNICIAN, NO ADVERSE EVENT OCCURRED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBEE 32 EEG GWQ EXCEL TECH. LTD. MOBEE 32 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN