BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILUMIEN OPTIS SYSTEM

    MDR report key: 6987282 · Received October 30, 2017

    Report

    Report Number
    3009600098-2017-00007
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 9, 2017
    Report Date
    December 19, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    NQQ
    PMA / PMN Number
    K123369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, LIMITING THE INVESTIGATION TO THE REVIEW OF THE DEVICE HISTORY RECORD AND FIELD SERVICE REPORT. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT-SJM MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. A FIELD SERVICE REPORT WAS PROVIDED NOTED THAT THE POWER CABLE WAS PLUGGED DIRECTLY TO THE WALL AND NOTED THAT A CIRCUIT BREAKER TRIPPED CAUSING THE REPORTED ISSUE. FURTHER INVESTIGATION FOUND A FAULTY POWER CABLE LEAD WAS REPLACED TO RESOLVE THE ISSUE AND CONFIRMED THAT AFTER REPLACING THE POWER LEAD CABLE, THE SYSTEM FUNCTIONED AS EXPECTED NO FURTHER ISSUES NOTED. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE RETURN STATUS OF THE REPORTED DEVICE, BUT NOTED ON COMMUNICATIONS THAT NO DEVICE WILL BE RETURNED FOR ANALYSIS AND NO FURTHER INFORMATION WILL BE EXPECTED. THE FILE WILL BE PROCESSED WITH THE INFORMATION AVAILABLE IF ADDITIONAL INFORMATION IS RECEIVED THE FILE WILL BE REOPENED AND WILL BE PROCESSED ACCORDINGLY. THE SYSTEM AND ITS SUB-ASSEMBLIES WERE ALL TESTED AND VERIFIED AS PART OF THE MANUFACTURING PROCESS AND THE UNIT WAS WITHIN SPECIFICATIONS AND COMPLETED TESTS PRIOR SHIPMENT FROM ABBOTT-SJM. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT WAS THE NONFUNCTIONAL POWER LEAD CABLE, THUS CAUSING THE REPORTED ISSUE AND SUBSEQUENTLY CAUSING THE ILUMIEN OPTIS SYSTEM CART TO GENERATE A LOUD NOISE AND SMOKE WHICH WAS POSSIBLY DUE TO EXTERNAL CONDITIONS AND HANDLING.

    Description of Event or Problem · 1

    SERVICE WAS PERFORMED AND A FAULTY POWER LEAD WAS FOUND. THE POWER LEAD WAS REPLACED RESOLVING THE ISSUE. PATIENT IDENTIFIER, AGE, WEIGHT AND GENDER IS PROTECTED UNDER LOCAL PRIVACY LAWS, AND THEREFORE IS NOT RECORDED.

    Description of Event or Problem · 1

    THE ILUMIEN OPTIS SYSTEM STARTED UP NORMALLY IN PREPARATION FOR A PROCEDURE. WHEN ATTEMPTING TO ENTER THE PATIENT DETAILS, A LOUD BANG WAS HEARD FROM THE BACK OF THE SYSTEM. THE SYSTEM WAS SMOKING AND SPARKS WERE SEEN AT THE SOCKET. THE SYSTEM WAS IMMEDIATELY SHUT DOWN AND REMOVED FROM THE LAB. IT HAS NOT BEEN USED SINCE. THE WALL SOCKET WAS INSPECTED BUT THE ONLY THING OBSERVED WAS A TRIPPED BREAKER. THE PATIENT PROCEDURE WAS COMPLETED WITHOUT THE SYSTEM WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765847 ILUMIEN OPTIS SYSTEM IMAGING SYSTEM NQQ ST. JUDE MEDICAL C408650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other