BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 19162288 · Received April 23, 2024

    Report

    Report Number
    3015232217-2024-00013
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ELEKTA SOLUTIONS AB
    Product Code
    IYE
    UDI-DI
    00858164002367
    PMA / PMN Number
    K203172
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED THAT THE COUCH MOVE ASSIST (CMA) BUTTON WAS NOT VISIBLE FOR A PATIENT WITH MULTIPLE TREATMENT SITES. DURING THE INVESTIGATION IT WAS FOUND THAT THE CUSTOMER'S NETWORK WAS SLOW. DUE TO THE SLOW SPEED OF THE CUSTOMER'S NETWORK, THE CHECKS THAT MOSAIQ PERFORMS SOMETIMES FINISH OUT OF SEQUENCE WHICH CAUSES THE CMA BUTTON TO NOT APPEAR. MOSAIQ ALLOWS FOR BOTH MANUAL AND/OR THE USE OF CMA FOR PATIENT POSITIONING. BECAUSE THE CMA BUTTON DID NOT APPEAR, THE POSITIONING WAS DONE MANUALLY AND THE PATIENT POSITION RE-IMAGED TO HELP MITIGATE ANY RISK. THIS IS A VALID WORKFLOW. THE INSTRUCTIONS FOR USE COVER BOTH MANUAL POSITIONING AND THE USE OF CMA. MOSAIQ® 3.1.3.0 INSTRUCTIONS FOR USE; SECTION 9.9.1 AND THE ELEKTA MEDICAL LINEAR ACCELERATOR INSTRUCTIONS FOR USE VOLUME 1 FOR: ELEKTA SYNERGY®, ELEKTA INFINITY¿, VERSA HD¿; SECTION 7. THE CUSTOMER MADE A CLINICAL DECISION TO RE-IMAGE THE PATIENT AFTER THE MANUAL POSITIONING, THEY RAISED A CONCERN OVER WHETHER THE SCAN WOULD IMPACT THE OVERALL DOSE RECEIVED BY THE PATIENT. THE KV RADIATION FROM THE WASTED SCAN IS UNLIKELY TO ADD ANY SIGNIFICANT DOSE TO THE TREATMENT OF THE PATIENT, AS ONLY MGY WOULD HAVE BEEN DELIVERED. THE RISK OF ADDITIONAL DOSE AS A RESULT OF WASTED SCANS HAS BEEN FULLY ASSESSED AND CONCLUDED THAT: EXTRA DOSE FROM WASTED KV SCANS SHOULD BE CONSIDERED IN THE CONTEXT OF THE OVERALL PLANNED TREATMENT DOSE. CALCULATIONS HAVE SHOWN THAT THE DOSE FROM A WASTED SCAN IS INSIGNIFICANT IN COMPARISON TO THE OVERALL TREATMENT DOSE. IT IS CONSIDERED EXTREMELY UNLIKELY THAT A USER WOULD ALLOW AN INDIVIDUAL PATIENT TO BE EXPOSED TO ENOUGH WASTED SCANS TO SIGNIFICANTLY INCREASE THEIR RISK OF DEVELOPING LOCAL RADIATION INDUCED MALIGNANCIES, OR TO ALLOW ENOUGH OVEREXPOSURE SO AS TO MAKE A WASTED SCAN ISSUE A SERIOUS ADVERSE EVENT REPORT. THE RISK TO THE PATIENT FROM WASTED SCAN DOSE IS CONSIDERED ACCEPTABLE, PARTICULARLY WHEN COMPARED AGAINST THE RISKS POSED BY INCORRECT PATIENT POSITIONING FOR MV TREATMENT. THIS ISSUE IS SITE SPECIFIC DUE TO THE CUSTOMER'S NETWORK SPEED. THERE WAS NO EVIDENCE OF MISTREATMENT. MOSAIQ WAS WORKING AS INTENDED AND DESIGNED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT CMA DOES NOT LAUNCH IN A PATIENT WITH MULTIPLE SITE SETUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942783 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA SOLUTIONS AB 00858164002367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown