BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAINLAB

    MDR report key: 2809447 · Received October 24, 2012

    Report

    Report Number
    MW5027386
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BRAIN LAB INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT WAS TAKEN TO OPERATING ROOM FOR A LEFT PARTIAL CRANIOTOMY FOR MASS. AFTER PT WAS PREPPED AND UNDER GENERAL ANESTHESIA, THE STEREOTACTIC GUIDANCE DEVICE WAS POWERED ON IT AND APPEARED TO FUNCTION APPROPRIATELY. THE MACHINE REACHED A LEVEL OF BEGINNING TO UPLOAD PT DATA AT WHICH TIME THE SCREEN TURNED BLUE AND INDICATED DIRECTIONS FOR RESETTING. MULTIPLE ATTEMPTS WERE MADE TO RESET/RESTART DEVICE, ALONG WITH A CONSULTATION WITH CLINICAL ENGINEERING/LOCAL SERVICE TECH. AFTER APPROX. ONE HOUR AND THE MULTIPLE OPTIONS THAT WERE ENTERTAINED, THE DECISION WAS MADE TO ABORT THE PROCEDURE AND RESCHEDULE AT A DIFFERENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAINLAB STEREOTACTIC GUIDANCE DEVICE HAW BRAIN LAB INC. VV2

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other