BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUSONE

    MDR report key: 8188884 · Received December 21, 2018

    Report

    Report Number
    3000256071-2018-00006
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    November 22, 2018
    Report Date
    November 22, 2018
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    PMA / PMN Number
    K152224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT ANALYSIS SHOWED THAT WHEN RESTARTING THE POWER SUPPLY, THE CURRENT OF THE MAGNETS INCREASED DIRECTLY TO ITS SETPOINT, WITHOUT CYCLING. SOFTWARE CODE REVIEW SHOWED THAT THIS CYCLING IS NOT PERFORMED IF DURING AN TREATMENT FIELD, THE "SET RANGE" IS NOT SUCCESSFULLY COMPLETED FOR ANY REASON (MANUAL PAUSE, DEVICE ERROR, MAGNET ISSUE,ETC.) AND A MAGNET POWER SUPPLY CURRENT DROPS BELOW THE REQUESTED CURRENT (E.G. IF THE POWER SUPPLY IS RE-BOOTED). AS A CONSEQUENCE, THE BEAM CHARACTERISTICS COULD BE WRONG WHEN STARTING IRRADIATION AFTER RESUMING THE TREATMENT FIELD. AS THERE IS A CYCLING OF THE MAGNETS BEFORE EACH TREATMENT BEAM, THE ISSUE WILL IMPACT ONLY ONE TREATMENT FIELD. IBA FURTHER ANALYZED THE RISK RELATED TO THIS EVENT AND CONCLUDED THAT THIS EVENT WOULD NOT LEAD TO A SERIOUS INJURY. IBA BELIEVES THAT THE EFFECTIVENESS OF THE TREATMENT WOULD NOT BE IMPACTED IF THIS ISSUE OCCURS AND THERE IS NOT AN ADDITIONAL RISK OF DELIVERING AN EXTRA DOSE TO THE ORGANS AT RISK.

    Description of Event or Problem · 0

    DURING A ROUTINE QUALITY ASSURANCE INSPECTION, ONE OF THE MAGNETS OF THE PROTON BEAM LINE FAILED. THE USER PAUSED THE BEAM AND IBA SITE TEAM POWER CYCLED THE POWER SUPPLIES OF ALL THE MAGNETS. THE USER THEN OBSERVED A RANGE ERROR OF 2MM COMPARED TO THE EXPECTED RANGE. NO ERROR MESSAGE WAS PROVIDED BY THE PROTON THERAPY SYSTEM.

    Additional Manufacturer Narrative · 1

    EVENT ANALYSIS SHOWED THAT WHEN RESTARTING THE POWER SUPPLY, THE CURRENT OF THE MAGNETS INCREASED DIRECTLY TO ITS SETPOINT, WITHOUT CYCLING. SOFTWARE CODE REVIEW SHOWED THAT THIS CYCLING IS NOT PERFORMED IF DURING AN TREATMENT FIELD, THE "SET RANGE" IS NOT SUCCESSFULLY COMPLETED FOR ANY REASON (MANUAL PAUSE, DEVICE ERROR, MAGNET ISSUE, ETC.) AND A MAGNET POWER SUPPLY CURRENT DROPS BELOW THE REQUESTED CURRENT (E.G. IF THE POWER SUPPLY IS RE-BOOTED). AS A CONSEQUENCE, THE BEAM CHARACTERISTICS COULD BE WRONG WHEN STARTING IRRADIATION AFTER RESUMING THE TREATMENT FIELD. AS THERE IS A CYCLING OF THE MAGNETS BEFORE EACH TREATMENT BEAM, THE ISSUE WILL IMPACT ONLY ONE TREATMENT FIELD.

    Description of Event or Problem · 1

    DURING A ROUTINE QUALITY ASSURANCE INSPECTION, ONE OF THE MAGNETS OF THE PROTON BEAM LINE FAILED. THE USER PAUSED THE BEAM AND IBA SITE TEAM POWER CYCLED THE POWER SUPPLIES OF ALL THE MAGNETS. THE USER THEN OBSERVED A RANGE ERROR OF 2MM COMPARED TO THE EXPECTED RANGE. NO ERROR MESSAGE WAS PROVIDED BY THE PROTON THERAPY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031742 PROTEUSONE PROTEUSONE LHN IBA (ION BEAM APPLICATIONS) PROTEUS 235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other