BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTINSIGHT

    MDR report key: 8120233 · Received November 30, 2018

    Report

    Report Number
    3000256071-2018-00005
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    October 31, 2018
    Report Date
    October 31, 2018
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    UDI-DI
    05404013830923
    PMA / PMN Number
    K132847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY IS PROVIDED IN EVENT.

    Description of Event or Problem · 0

    IBA HAS BEEN INFORMED THAT ON OCTOBER 31, 2018 DURING DAILY CHECKS PERFORMED ON THE SYSTEM, AN UNEXPECTED SHIFT IN POSITION OF A PHANTOM INSTALLED ON THE PATIENT POSITIONING SYSTEM WAS OBSERVED. THE PROCESSING UNIT WAS POWERCYCLED AND ADAPTINSIGHT WORKSTATION WAS RESTARTED. AFTERWARDS, THE SAME TEST AS ABOVE WAS PERFORMED AND THIS TIME THE PHANTOM WAS STILL ALIGNED PROPERLY. NO PATIENT WAS INVOLVED. EVALUATION SUMMARY: ANALYSIS OF THE EVENT IDENTIFIED A WHITE BAND ON THE SIDE OF ONE THIRD PARTY FLAT PANEL AS THE CAUSE OF THE SHIFT IN THE PHANTOM POSITION. THIRD PARTY SUPPLIER HAS BEEN INFORMED OF THIS ISSUE AND CONFIRMED THAT THEY HAD NOT BEEN NOTIFIED OF SUCH A DEFECT PREVIOUSLY. AS THE ISSUE IS NOT REPRODUCIBLE, IT IS CURRENTLY NOT POSSIBLE TO CONDUCT FURTHER ANALYSIS OF THIS ONE-TIME EVENT WITH THIRD PARTY FLAT PANEL. THE PANEL WILL BE MONITORED IN ORDER TO COLLECT ADDITIONAL DATA IN CASE OF A NEW OCCURRENCE.

    Description of Event or Problem · 1

    IBA HAS BEEN INFORMED THAT ON (B)(6) 2018 DURING DAILY CHECKS PERFORMED ON THE SYSTEM, AN UNEXPECTED SHIFT IN POSITION OF A PHANTOM INSTALLED ON THE PATIENT POSITIONING SYSTEM WAS OBSERVED. THE PROCESSING UNIT WAS POWER CYCLED AND ADAPT INSIGHT WORKSTATION WAS RESTARTED. AFTERWARDS, THE SAME TEST AS ABOVE WAS PERFORMED AND THIS TIME THE PHANTOM WAS STILL ALIGNED PROPERLY. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961237 ADAPTINSIGHT I2C LHN IBA (ION BEAM APPLICATIONS) I2C 05404013830923

    Patients

    Seq Age Sex Outcome Treatment
    1