BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 11677572 · Received April 16, 2021

    Report

    Report Number
    2950347-2021-00005
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 4, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002282
    PMA / PMN Number
    K183034
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THIS COMPLAINT WAS RECEIVED VIA A THIRD PARTY (VARIAN). THE CUSTOMER WOULD LIKE TO ESTABLISH WHY THE RECORDING OF KV SETUP FIELDS IN MOSAIQ ARE DISPLAYING THE ORIGINAL COUCH POSITION WHERE THE IMAGE CAPTURED, AND NOT THE SHIFTED TREATMENT POSITION. THE CUSTOMER WAS EXPECTING TO SEE THE SHIFTED POSITION. IT WAS ASCERTAINED THAT THE CUSTOMER LOOKED AT THE RECORD OF KV SETUP FIELD IN THE TREATMENT CHART WINDOW. THE COUCH POSITIONS RECORDED FOR THE KV SETUP FIELD WERE AT THE IMAGE ACQUISITION POSITIONS AND NOT AT THE POSITIONS AFTER THE SHIFTS WERE MADE. IF THE CUSTOMER WOULD LIKE TO SEE THE SHIFT INFORMATION FOR THE KV SETUP FIELD, THEY WILL NEED TO GO TO THE IMAGE LIST WINDOW. ELEKTA HAVE CONFIRMED THAT THE CUSTOMER WAS USING THE CORRECT WORKFLOW WHEN INTERFACING WITH VARIAN TRUEBEAM. MOSAIQ DID NOT HAVE ANY MALFUNCTION AND IS WORKING AS DESIGNED AND INTENDED AND BASED ON THE AVAILABLE INFORMATION THERE HAS BEEN NO MISTREATMENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS RECEIVED VIA A THIRD PARTY (VARIAN). THE CUSTOMER WOULD LIKE TO ESTABLISH WHY THE RECORDING OF KV SETUP FIELDS, MOSAIQ IS DISPLAYING THE ORIGINAL COUCH POSITION WHERE THE IMAGE CAPTURE, AND NOT THE SHIFTED TREATMENT POSITION. THE CUSTOMER WAS EXPECTING TO SEE THE SHIFTED POSITION.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COUCH POSITION IS NOT SAVING BACK CORRECTLY TO MOSAIQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575782 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC MOSAIQ 00858164002282

    Patients

    Seq Age Sex Outcome Treatment
    1