BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLTEK EMU40 EEG HEADBOX

    MDR report key: 2057624 · Received March 7, 2011

    Report

    Report Number
    9612330-2011-00001
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 4, 2011
    Manufacturer
    EXCEL-TECH LTD.
    Product Code
    GWQ
    PMA / PMN Number
    K053386
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: ON (B)(6) 2011, XLTEK TECHNICAL SUPPORT DEPARTMENT RECEIVED A PHONE CALL FROM (B)(6) HOSPITAL ASKING FOR RETURN AUTHORIZATION TO RETURN NON-FUNCTIONAL: EMU40 BREAKOUT BOX. THE EMU40 HEADBOX IS AN ELECTROENCEPHALOGRAPH THAT IS USED TO ACQUIRE, DIGITIZE, STORE AND TRANSMIT PHYSIOLOGICAL SIGNALS FOR EEG STUDIES. ACCORDING TO THE CUSTOMER, THE UNIT STOPPED WORKING DURING ROUTINE EEG RECORDING. THE UNIT WAS RECEIVED FOR REPAIR AT XLTEK ON (B)(6) 2011. ON (B)(6) 2011, AS PART OF ROUTINE SERVICING ACTIVITY, THE REPAIR TECH FOUND BURNED COMPONENT OF THE PRINTED CIRCUIT BOARD ASSEMBLY AND REPORTED THE FAILURE TO THE QA DEPARTMENT. A FORMAL COMPLAINT WAS CREATED FOLLOWING COMPLAINT HANDLING PROCEDURE (B)(4). AN INVESTIGATION WAS LAUNCHED TO FIND THE ROOT CAUSE OF THE FAILURE AND ALSO ASSESSMENT OF POTENTIAL HARM TO A PT OR USER, IF THIS TO RE-OCCUR. AS THE INVESTIGATION HAS BEEN COMPLETED, BY MEANS OF THIS REPORT HEREWITH, THE DETAILS OF INVESTIGATION AND CONCLUSION ARE PRESENTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AS PART OF ROUTINE SERVICING ACTIVITY, THE REPAIR TECH FOUND BURNED COMPONENT OF THE PRINTED CIRCUIT BOARD ASSEMBLY AND REPORTED THE FAILURE TO THE QA DEPARTMENT. AN INVESTIGATION WAS LAUNCHED TO FIND THE ROOT CAUSE OF THE FAILURE AND ALSO ASSESSMENT OF POTENTIAL HARM TO A PT OR USER, IF THIS TO RE-OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XLTEK EMU40 EEG HEADBOX ELECTROENCEPHALOGRAPH HEADBOX GWQ EXCEL-TECH LTD. EMU40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA