BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIQ

    MDR report key: 11670264 · Received April 15, 2021

    Report

    Report Number
    2950347-2021-00004
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 17, 2021
    Report Date
    June 21, 2021
    Manufacturer
    ELEKTA INC
    Product Code
    IYE
    UDI-DI
    00858164002091
    PMA / PMN Number
    K141572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D3 FAX NUMBER UPDATED. SECTION H6 CODING UPDATED. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. BASED ON THE DATA ANALYSED, THE MLC LEAVES WERE IN THE APPROPRIATE POSITIONS WHEN TREATMENT WAS DELIVERED FOR FIELD 1 AND FIELD 2. HOWEVER, IT APPEARS THAT FIELD 2 WAS INCORRECTLY ASSOCIATED WITH THIS TREATMENT AS THE PATIENT WAS UNDERTREATED BY 4.3 MU. BOTH ELEKTA AND THE CUSTOMER HAVE BEEN UNABLE TO REPRODUCE THE ISSUE. THIS APPEARS TO BE A ONE-TIME OCCURRENCE AND THE CAUSE IS UNKNOWN AND ELEKTA ARE THEREFORE UNABLE TO DETERMINE A ROOT CAUSE FOR THE PROBLEM. BASED ON THE AVAILABLE INFORMATION, ELEKTA PHYSICS HAVE ASSESSED THE UNDERDOSE TO THE PATIENT WOULD BE NEGLIGIBLE. NO REMEDIAL TREATMENT WAS REQUIRED.

    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 A PATIENT HAD ANTERIOR AND POSTERIOR BEAMS. THE SITE DID A CBCT WHICH ENDED AT 180 DEG. THE USER SELECTED THE POSTERIOR BEAM AND THE SYSTEM WENT TO 0 DEG WHERE THE BEAM WAS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572472 MOSAIQ ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA INC MOSAIQ 00858164002091

    Patients

    Seq Age Sex Outcome Treatment
    1