BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUSPLUS

    MDR report key: 12874261 · Received November 25, 2021

    Report

    Report Number
    3000256071-2021-00003
    Event Type
    Malfunction
    Date Received
    November 25, 2021
    Date of Event
    October 21, 2021
    Report Date
    October 26, 2021
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    PMA / PMN Number
    163500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3: EVALUATION SUMMARY IS PROVIDED IN SECTION B5.

    Description of Event or Problem · 0

    DESCRIPTION OF THE EVENT (FROM INITIAL REPORT): ON (B)(6) 2021, IBA DETECTED THAT THE SCANNING CONTROLLER GATEWAY (SCGW) PROCESS WAS RUNNING ON THE TEST ENVIRONMENT INSTEAD OF THE CLINICAL ENVIRONMENT (EVENT RECORDED UNDER IBA REF PR (B)(4)). EVENT ANALYSIS SHOWED THAT THIS CONFIGURATION WAS PRESENT DURING TWO DAYS OF PATIENT TREATMENTS. IMPACT OF THE EVENT ON THE PATIENTS (FROM INTIAL REPORT): FURTHER ANALYSIS SHOWED THAT THE SCANNING CONTROLLER SETUP FILES WERE IDENTICAL IN THE TEST AND CLINICAL ENVIRONMENTS. THEREFORE, THIS EVENT HAD NO IMPACT ON PATIENT TREATMENTS. IMMEDIATE ACTION (FROM INITIAL REPORT): ON (B)(6) 2021, THE SCGW PROCESS RUNNING ON THE TEST ENVIRONMENT WAS COMPLETELY SHUTDOWN AND THE CLINICAL VERSION WAS STARTED, WHICH RESOLVED THE ISSUE. EVALUATION SUMMARY (SUPPLEMENTAL REPORT): IBA IDENTIFIED THAT INITIATING THE STARTUP OF THE CLINICAL PROCESSES IN THE CLINICAL ENVIRONMENT IS NOT PREVENTED EVEN IF SOME TEST PROCESSES OF THE TEST ENVIRONMENT ARE STILL RUNNING. THIS ISSUE AFFECTS THE PROTON THERAPY SYSTEM SOFTWARE VERSIONS PTS-8 BEFORE VERSION PTS-8.7.2. IT MAY LEAD TO SITUATIONS WHERE THE SYSTEM IS USING TEST PROCESSES WITHOUT NOTIFYING THE CLINICAL USER. IF THE VERSIONS OF THE PROCESSES ARE DIFFERENT BETWEEN BOTH ENVIRONMENTS, THIS COULD HAVE AN IMPACT ON PATIENT TREATMENTS. FOR THIS REASON, IBA INITIATED A RECALL - URGENT MEDICAL DEVICE CORRECTION (SEE RECALL REPORT IBA REF.121508 - NO FDA REFERENCE RECEIVED SO FAR). PLEASE REFER TO THE RECALL REPORT FOR ADDITIONAL DETAILS.

    Description of Event or Problem · 0

    DESCRIPTION OF THE EVENT: ON (B)(6) 2021, IBA DETECTED THAT THE SCANNING CONTROLLER GATEWAY (SCGW) PROCESS WAS RUNNING ON THE TEST ENVIRONMENT INSTEAD OF THE CLINICAL ENVIRONMENT (EVENT RECORDED UNDER IBA REF PR (B)(4)). EVENT ANALYSIS SHOWED THAT THIS CONFIGURATION WAS PRESENT DURING TWO DAYS OF PATIENT TREATMENTS. IMPACT OF THE EVENT ON THE PATIENTS: FURTHER ANALYSIS SHOWED THAT THE SCANNING CONTROLLER SETUP FILES WERE IDENTICAL IN THE TEST AND CLINICAL ENVIRONMENTS. THEREFORE, THIS EVENT HAD NO IMPACT ON PATIENT TREATMENTS. IMMEDIATE ACTION: ON (B)(6) 2021, THE SCGW PROCESS RUNNING ON THE TEST ENVIRONMENT WAS COMPLETELY SHUTDOWN AND THE CLINICAL VERSION WAS STARTED, WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772424 PROTEUSPLUS PROTON THERAPY SYSTEM LHN IBA (ION BEAM APPLICATIONS) PROTEUS 235

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other