BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    !M1

    MDR report key: 14247707 · Received April 29, 2022

    Report

    Report Number
    3013677815-2022-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Report Date
    May 11, 2022
    Manufacturer
    SOLUTIONS FOR TOMORROW AB
    Product Code
    IZL
    PMA / PMN Number
    K170607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RCA SHOWS HUMAN ERROR. SCREWS WERE NOT TIGHTENED FROM MANUFACTURER. TO PREVENT RE-OCCURRENCE IN THE PRODUCTION PROCESS, AN EXTRA CONTROL CHECK WILL BE IMPLEMENTED IN PRODUCTION TO SECURE THAT THE SCREWS ARE TIGHTENED CORRECTLY. THE DETECTION OF THE DESCRIBED MALFUNCTION (LOOSE COLLIMATOR) IS ASSESSED TO BE VERY OBVIOUS. THERE WILL BE ABNORMAL NOISES AND OCULAR DETECTION IS EASY. THE IFU STATES THAT DAILY VISUAL INSPECTION OF THE DEVICE SHALL BE PERFORMED BEFORE USE. ONLY TRAINED PERSONNEL ARE ALLOWED TO OPERATE THE SYSTEM. WE CONSIDER THIS AS A ONE TIME EVENT, THIS IS THE FIRST REPORTED MALFUNCTION OF THIS KIND, WE HAVE AN INSTALLED BASE OF (B)(4) UNITS WORLD WIDE SINCE APRIL 2016. BASED ON THE VERY LOW FREQUENCY AND THE EASY DETECTION WE CONSIDER THAT PREVENTIVE ACTION IN THE PRODUCTION PROCESS IS SUFFICIENT.

    Description of Event or Problem · 0

    DURING MAINTENANCE OF THE ACTUAL DEVICE IT WAS DISCOVERED THAT THE COLLIMATOR WAS LOOSE. THERE WAS A RATTLING SOUND AND YOU COULD SEE A GAP OF APPROXIMATELY 2 CM AT THE ATTACHMENT BETWEEN THE COLLIMATOR AND THE TUBE. WHEN THE SERVICE ENGINEER DROVE THE COLUMN THE COLLIMATOR LOOSENED. NO PATIENT INVOLVEMENT, HAPPENED DURING SCHEDULED MAINTENANCE OF THE DEVICE.

    Description of Event or Problem · 0

    DURING MAINTENANCE OF THE ACTUAL DEVICE IT WAS DISCOVERED THAT THE COLLIMATOR WAS LOOSE. THERE WAS A RATTLING SOUND AND YOU COULD SEE A GAP OF APPROXIMATELY 2 CM AT THE ATTACHMENT BETWEEN THE COLLIMATOR AND THE TUBE. WHEN THE SERVICE ENGINEER DROVE THE COLUMN THE COLLIMATOR LOOSENED. NO PATIENT INVOLVEMENT, HAPPENED DURING SCHEDULED MAINTENANCE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100185 !M1 MODELONE IZL SOLUTIONS FOR TOMORROW AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown