BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNEXION IMAGING MODULE

    MDR report key: 7410597 · Received April 10, 2018

    Report

    Report Number
    9710332-2018-00001
    Event Type
    Malfunction
    Date Received
    April 10, 2018
    Report Date
    June 14, 2018
    Manufacturer
    MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH
    Product Code
    IXQ
    UDI-DI
    04056719001193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE BROKEN IMAGING MODULE WAS SENT TO THE SUPPLIER FOR ROOT CAUSE ANALYSIS, HOWEVER THE BREAKAGE COULD NOT BE DETERMINED. THE RISK ASSESSMENT AND THE DYNAMIC AND STATIC OVERLOAD TESTS CONCLUDE THAT THE CURRENT DESIGN IS SAFE AND NO FAILURES IN THE MANUFACTURING PROCESS CAN BE DETECTED. THE FRACTION PATTERN HOWEVER, INDICATES A POTENTIAL EARLIER DYNAMIC OVERLOAD WHICH MIGHT HAVE PREDAMAGED THE BOARD AND MOST LIKELY OCCURRED IN THE FIELD AFTER INSTALLATION.

    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 WHILST POSITIONING A PATIENT, THE MIDDLE SECTION OF THE TABE TOP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253804 CONNEXION IMAGING MODULE SYSTEM, PLANNING, RADIATION THERAPY TREATMENT IXQ MEDICAL INTELLIGENCE MEDIZINTECHNIK GMBH P10105-210 P10105-210 04056719001193

    Patients

    Seq Age Sex Outcome Treatment
    1