BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS AGILE

    MDR report key: 20618433 · Received November 6, 2024

    Report

    Report Number
    3004977335-2024-00131
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 30, 2024
    Report Date
    March 27, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    JAA
    PMA / PMN Number
    K111292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE REPORTED ISSUE WAS INVESTIGATED IN DETAIL. IT WAS REPORTED THAT THE CABLE TROLLEY FELL OFF THE CEILING. THE ANALYSIS OF THE PROVIDED PICTURES INDICATED SIGNS OF WEAR AND INTENSE USAGE. THE CARRIAGE COVER WAS FOUND TO BE BROKEN AND SHOWED CRACKS. THE AFFECTED CABLE TROLLEY WAS RETURNED. THE INVESTIGATION OF THIS PART CONFIRMED THE DAMAGES WHICH WERE ALREADY SEEN IN THE PICTURES. THE INVESTIGATION SHOWED THAT THE CABLE TROLLEY FELL OFF BECAUSE THE EDGE OF THE GROOVE THAT SHOULD HOLD THE SNAP RING WAS BROKEN. THE SNAP RING CAME OFF AND THE ROLL WAS NOT HELD IN PLACE ANYMORE. THE ROLL MOVED OFF FROM THE BEARING AND SO THE CABLE TROLLEY WAS ABLE TO SLIP OUT OF THE CEILING RAIL. IN THIS CASE IT STILL HUNG ON THE CABLES. SUCH A DAMAGE CANNOT BE GENERATED DURING THE NORMAL INTENDED USE OF THE DCS UNIT. LATERAL FORCE MUST HAVE BEEN APPLIED TO THE CABLE TROLLEY. SINCE THE CABLE TROLLEY SHOULD ONLY BE MOVED IN THE DIRECTION OF THE RAIL FORCES THAT ARE APPLIED FROM THE SIDE MUST BE HANDLED BY THE ROLLS. TYPICAL LATERAL FORCES WOULD BE PULLING THE CABLES SIDEWAYS (BY HAND OR BY A MOVABLE DEVICE IN THE ROOM) OR THE PULLEY WAS SOMEHOW HIT. SIEMENS HEALTHINEERS INTERNAL POST MARKET SURVEILLANCE DOES NOT INDICATE A GENERAL PROBLEM WITH THE COMPONENTS, NEITHER WITH THE CABLE TROLLEY MATERIAL NUMBER (7111821) NOR WITH THE CARRIAGE COVER (KIT) 13 MATERIAL NUMBER (7111664). BASED ON THE INVESTIGATION RESULTS THE ISSUE CAN ONLY BE ATTRIBUTED TO INADEQUATE HANDLING. THE CABLE TROLLEY ISSUE HAS BEEN REPAIRED AT CUSTOMER SITE. THE COMPLAINT IS CLOSED AND FURTHER ACTION BY SIEMENS IS NOT WARRANTED.

    Additional Manufacturer Narrative · 0

    D4: NOT APPLICABLE. PRIMARY UDI NUMBER - DUE TO THE AGE OF THE COMPLAINT SYSTEM, A GTIN IS NOT AVAILABLE. H6: INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): CURRENTLY, NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES AN IMMEDIATE ACTION. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE ROOT CAUSE FOR THE ISSUE HAS NOT YET BEEN DETERMINED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA IF ADDITIONAL INFORMATION IS OBTAINED AFTER THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS BECAME AWARE OF AN ISSUE WITH THE LUMINOS AGILE SYSTEM. IT WAS COMMUNICATED THAT THE CORRUGATED HOSE HOLDER OF THE DISPLAY CEILING STAND DETACHED FROM THE RAIL AND WAS DANGLING FROM THE CEILING, STILL ATTACHED TO THE CABLE BUNDLE. NO INJURY TO PATIENTS, USERS, OR OTHERS WAS COMMUNICATED TO SIEMENS HEALTHINEERS DUE TO THE REPORTED EVENT. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO, A MINOR TO SERIOUS INJURY COULD RESULT FROM THE FALLING PARTS IF THE EVENT WERE TO REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430138 LUMINOS AGILE SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA SIEMENS HEALTHINEERS AG 10502200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown