BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 20084569 · Received August 28, 2024

    Report

    Report Number
    3015232217-2024-00026
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    July 25, 2024
    Report Date
    December 9, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    07340201500026
    PMA / PMN Number
    K203172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    D4: UPDATED. H4: MANUFACTURING DATE IS NOT ON THE LABEL, BUT IT IS KNOWN SO FIELD H4 HAS BEEN COMPLETED WITH THIS INFORMATION. H11 UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE WAS DETERMINED TO BE A DEFECT BUT IS NOT CONSIDERED SAFETY. THE CUSTOMER REPORTED THAT A HITACHI TREATMENT DOSE DID NOT RECORD IN MOSAIQ. IT WAS DETERMINED THAT THE COMPUTER CONNECTED TO THE TREATMENT MACHINE, WHICH IS REFERRED TO AS THE SEQUENCER, RECEIVED A "COMPLETE" STATE PREMATURELY. THE LOGS SHOWED THE SEQUENCER HAD SWITCHED TO A COMPLETION STATE WHILE THE TREATMENT WAS STILL IN PROGRESS ON THE PARTICLE MACHINE. MOSAIQ AND THE PARTICLE MACHINE WERE OUT OF SYNC AND THE TREATMENT THEN HAD TO BE MANUALLY RECORDED. THE TREATMENT WAS SUCCESSFULLY COMPLETED, BUT WAS NOT RECORDED IN MOSAIQ. MOSAIQ DISPLAYED A MESSAGE TO THE USER INDICATING THAT THERE WAS NO RECORDING. THE USER RECORDED THE TREATMENT MANUALLY. THERE WAS NO PATIENT MISTREATMENT. THIS IS A RECORDING ISSUE ONLY AND SHOULD THE ISSUE OCCUR AGAIN, IT WOULD NOT RESULT IN PATIENT HARM AS WITH THE DATA FROM THE MACHINE LOG, THE USER (WITH HELP FROM OUR PRODUCT SUPPORT) WOULD BE ABLE TO VERIFY THE ACTUAL TREATMENT AND THE TREATMENT COULD BE MANUALLY RECORDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A HITACHI TREATMENT DOSE DID NOT RECORD IN MOSAIQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198366 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB VERSION 3.1.3.2 07340201500026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown