BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    !M1

    MDR report key: 10366197 · Received August 5, 2020

    Report

    Report Number
    3013677815-2020-00002
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 7, 2020
    Report Date
    September 14, 2020
    Manufacturer
    SOLUTIONS FOR TOMORROW AB
    Product Code
    IZL
    PMA / PMN Number
    K170607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE ANALYSIS POINTS AT ASSEMBLY ERROR IN PRODUCTION. DURING A PERIOD IN PRODUCTION THE TUBE HEAD NUT FASTENER, MAY BE INCORRECT TIGHTENED. TO SECURE ALL AFFECTED SYSTEMS IN THE IDENTIFIED RANGE, WE HAVE INITIATED A FIELD ACTION TO VERIFY THAT THE NUT FIXATION IS DONE CORRECTLY. PRODUCTION PERSONNEL HAS BEEN RE-TRAINED IN THE MANUFACTURING PROCESS. NO AFFECTED SYSTEM HAS BEEN DELIVERED TO THE US.

    Description of Event or Problem · 0

    THE NUT HOLDING THE TUBE HEAD IN POSITION HAD COME LOOSE AND THE WHOLE TUBE HEAD ASSEMBLY WAS TILTING FORWARDS. IT WAS DETECTED DURING NORMAL WORKING CONDITIONS BY THE X-RAY TECHNICIAN. NOBODY WAS INJURED. AFTER THE NUT WAS TIGHTENED THE SYSTEM COULD BE USED NORMALLY.

    Description of Event or Problem · 1

    THE NUT HOLDING THE TUBE HEAD IN POSITION HAD COME LOOSE AND THE WHOLE TUBE HEAD ASSEMBLY WAS DROPPING FORWARDS. IT WAS DETECTED DURING NORMAL WORKING CONDITIONS BY THE X-RAY TECHNICIAN. NOBODY WAS INJURED. AFTER THE NUT WAS TIGHTENED THE SYSTEM COULD BE USED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831668 !M1 !M1 MODEL ONE IZL SOLUTIONS FOR TOMORROW AB A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other