BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEUSPLUS

    MDR report key: 10168195 · Received June 18, 2020

    Report

    Report Number
    3000256071-2020-00003
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 20, 2020
    Report Date
    May 20, 2020
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    UDI-DI
    05404013814015
    PMA / PMN Number
    K163500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY IS PROVIDED IN SECTION B5 (DESCRIBE EVENT OR PROBLEM).

    Description of Event or Problem · 0

    EVENT DESCRIPTION (FROM INITIAL REPORT) : ON (B)(6) 2020, DURING THE PREPARATION FOR A TREATMENT, AN ABORT OCCURRED WHEN AN ABNORMAL BEAM WAS DETECTED. IT WAS NOT POSSIBLE TO RESUME MANUALLY THE PARTIAL TREATMENT FROM DCEU (DOSIMETRY COUNTER ELECTRONIC UNIT) VALUE, BUT THE TPS (TREATMENT PLANNING SYSTEM) WAS USED TO MAKE A SINGLE PRESCRIBED BEAM OF THE NORMAL BEAM SKIPPING THE ALREADY DELIVERED SPOTS. PRELIMINARY ANALYSIS (FROM INITIAL REPORT) : THE ISSUE IS UNDER ANALYSIS AND IS REPORTED PREVENTIVELY. SUPPLEMENTAL REPORT WILL INCLUDE ANALYSIS OF THE ISSUE. EVALUATION SUMMARY (SUPPLEMENTAL REPORT): DURING THE ANALYSIS OF THE (B)(6) 2020 EVENT, IBA IDENTIFIED AN ISSUE WITH THE PROTON THERAPY SYSTEM SOFTWARE VERSIONS PTS-12.0.0, PTS- 12.0.1 AND PTS-12.0.1.1. WHEN USING THE IBA PROTON THERAPY SYSTEM IN COMBINATION WITH AN OIS IN DEVICE CENTRIC MODE, IF AN IRRADIATION ABORT OCCURS RESULTING IN A CORRUPTED OR UNAVAILABLE TREATMENT RECORD, THE CURRENT PTS SOFTWARE DOES NOT PERMIT IN A STRAIGHFORWARD WAY, THE DELIVERY OF THE ABORTED BEAM THROUGH THE OIS. IBA INITIATED A MEDICAL DEVICE CORRECTION (SEE RECALL REPORT IBA REF. PR-115141 - RES 86076 / Z-2715-2020). PLEASE REFER TO THE RECALL REPORT FOR ADDITIONAL DETAILS.

    Description of Event or Problem · 1

    EVENT DESCRIPTION : ON (B)(6) 2020, DURING THE PREPARATION FOR A TREATMENT, AN ABORT OCCURRED WHEN AN ABNORMAL BEAM WAS DETECTED. IT WAS NOT POSSIBLE TO RESUME MANUALLY THE PARTIAL TREATMENT FROM DCEU (DOSIMETRY COUNTER ELECTRONIC UNIT) VALUE, BUT THE TPS (TREATMENT PLANNING SYSTEM) WAS USED TO MAKE A SINGLE PRESCRIBED BEAM OF THE NORMAL BEAM SKIPPING THE ALREADY DELIVERED SPOTS. PRELIMINARY ANALYSIS : THE ISSUE IS UNDER ANALYSIS AND IS REPORTED PREVENTIVELY. SUPPLEMENTAL REPORT WILL INCLUDE ANALYSIS OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632473 PROTEUSPLUS PROTON THERAPY SYSTEM LHN IBA (ION BEAM APPLICATIONS) PROTEUS 235 05404013814015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other