BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIX TOP

    MDR report key: 12048606 · Received June 23, 2021

    Report

    Report Number
    3004977335-2021-85157
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 23, 2021
    Product Code
    IZZ
    PMA / PMN Number
    K971452
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE WAS INVESTIGATED IN DETAIL. THE INVESTIGATION OF THE PROVIDED PICTURES SHOWED THAT THE GROOVED HOSE HOLDER FROM THE TRANSVERSE CARRIAGE HAD DETACHED AND FALLEN. THE DESCRIPTION IN THE COMPLAINT TEXT "BOLT HIT THE FLOOR" COULD NOT BE CONFIRMED, ONLY THE SMALL SCREW NUT HIT THE FLOOR. THE GROOVED TUBE STOPPED AT A HEIGHT OF APPROX. 60 CM OVER THE TABLETOP. IT WAS DETERMINED THAT THE CAUSE OF THE GROOVED HOSE WITH THE CABLE HOLDER FALLING WAS THE LOOSENING OF THE NUT FROM THE BOLT ON THE CABLE HOLDER. IT IS ASSUMED THAT THE SCREW CONNECTION OF THE HOLDER WAS SECURED WITHOUT ANY LOCTITE, WHICH ALLOWED THE CONNECTION TO GET LOOSE OVER TIME. IT COULD NOT BE DETERMINED WHETHER THE CONNECTION WAS NOT SECURED WITH LOCTITE DURING PRODUCTION OR THROUGH SERVICE MEASURES. HOWEVER, THE SLEEVE DOES NOT MAKE ANY DOWNWARD ROTATION DURING FALL; ONLY AT THE END OF FALLING THE SLEEVE IS ROTATED. THIS WAS SIMULATED AND CONFIRMED IN THE TEST LABORATORY. THE SLEEVE OF THE CABLE HOLDER IS MADE OF PLASTIC. ACCORDING TO THE INFORMATION RECEIVED FROM LOCAL SERVICE, THE HOLDER ON SITE WAS REATTACHED, INSPECTED AND THE MOUNTING WAS TESTED. THE CONNECTION WAS SECURED WITH LOCTITE. NO FURTHER MEASURES ARE NECESSARY AT THE CONCERNED CUSTOMER SITE. IT WAS STATED THAT THERE WAS NO EVIDENCE OF LOCTITE ON THE THREADED PART OF THE HANGER. BASED ON THE INSTRUCTIONS, THE SCREW CONNECTION MUST BE SECURED WITH LOCTITE DURING INSTALLATION. THE MANUFACTURING DOCUMENTS WERE SCREENED AND WERE FOUND AS CORRECT. HOWEVER, IT WAS DECIDED TO SPECIFY THE MAINTENANCE INSTRUCTIONS IN MORE DETAILS AS A PREVENTIVE MEASURE. GENERAL INSPECTION OF THE GROOVED HOSE HOLDER MUST BE SUBSTITUTED BY A DETAILED INSPECTION OF THE CABLE HOLDER DURING MAINTENANCE. THIS INSPECTION WILL BE DESCRIBED MORE EXPLICITLY IN THE MAINTENANCE PROTOCOL.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID # (B)(4).

    Description of Event or Problem · 1

    AN ISSUE OCCURRED WITH A MULTIX TOP SYSTEM. THE USER REPORTED THAT THE BOLT FROM THE 3D CARRIAGE CONDUIT MOUNT DROPPED AND ONE OF THE CABLES BECAME FREE. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. AT THIS TIME, THE SYSTEM HAS BEEN TAKEN OUT OF USE. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT. THE ISSUE IS REPORTED IN DOUBT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948164 MULTIX TOP TABLE, RADIOGRAPHIC, NON-TILTING, POWERED IZZ 475517

    Patients

    Seq Age Sex Outcome Treatment
    1 Other