BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLTEK EP16 LAPTOP

    MDR report key: 454634 · Received April 10, 2003

    Report

    Report Number
    9612330-2003-00001
    Event Type
    Malfunction
    Date Received
    April 10, 2003
    Date of Event
    March 13, 2003
    Manufacturer
    EXCEL TECH. LTD.
    Product Code
    GWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING CAROTID ENDARTERECTOMY, THE TECHNICIAN SMELLED ELECTRICAL BURNING ODOR FROM THE LAPTOP POWER SUPPLY. THEY CONTINUED USING THE DEVICE BECAUSE THE PATIENT WAS ALREADY SHUNTED BEFORE THE SMELL OCCURRED. AFTER THE OPERATION, THE TECHNICIAN TURNED THE POWER OFF AND NOTICED THAT THE POWER SUPPLY OVERHEATED. THE POWER CORD MELTED INTO THE OUTLET. ACCORDING TO THE TECHNICIAN, NO PARALYSIS OR SENSORY LOSS OCCURRED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XLTEK EP16 LAPTOP EVOKED RESPONSE ELECTRICAL STIMULATOR GWF EXCEL TECH. LTD. EP16 LAPTOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other