BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS LOTUS MAX

    MDR report key: 21524229 · Received March 5, 2025

    Report

    Report Number
    3004977335-2025-00032
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    March 3, 2025
    Report Date
    June 2, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    4056869269931
    PMA / PMN Number
    K173639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL DATA. G5: THE 510(K) OF LUMINOS LOTUS MAX IS K173639. H3, H6: SIEMENS HEALTHINEERS COMPLETED THE DETAILED INVESTIGATION OF THE REPORTED ISSUE. IT WAS STATED THAT THE COVER OF THE DISPLAY CEILING SUSPENSION (DCS) FELL OFF AND WIRES WERE EXPOSED. IN GENERAL, THE AFFECTED COVERS ARE ONLY FOR AESTHETIC PURPOSES. THERE IS NO RISK OF ELECTRICAL SHOCK DUE TO THE EXPOSED WIRES. ACCORDING TO THE INFORMATION RECEIVED THE HOSPITAL STAFF ALREADY NOTICED THAT THE COVER (CANOPY) WAS LOOSE AND HANGING DOWN BEFORE IT FINALLY FELL OFF. IF A DAMAGED OR LOOSE PART IS IDENTIFIED DURING DAILY CHECK, IT MUST BE REPAIRED BEFORE RESUMING PATIENT EXAMINATIONS. THIS IS ALSO STATED IN THE OPERATOR MANUAL. THE ANALYSIS OF THE PROVIDED PICTURES SHOWED THAT THE PLASTIC MOUNTING FLAPS WERE BROKEN AND THUS THE SCREWS COULD NOT HOLD THE TWO COVER PARTS TOGETHER. SINCE ONLY THE SNAPPING MECHANISM WAS LEFT TO HOLD THE COVER, IT FINALLY FELL OUT. POTENTIALLY, THE CABLES THAT ARE HIDDEN BEHIND THE CANOPY PUT SLIGHT PRESSURE TO THE COVER. WITH ADDITIONAL FORCE APPLIED TO THE COVER DURING MOVEMENT OF THE DCS, THIS MIGHT HAVE CONTRIBUTED TO THE COVER FALLING OFF. THE RELATED START UP REPORT INDICATES THAT THE DCS WAS INSTALLED CORRECTLY. IT COULD NOT BE DETERMINED WHAT CAUSED THE MOUNTING FLAPS TO BREAK. THIS COULD ALSO BE THE RESULT OF A COLLISION EVEN THOUGH NO COLLISION SIGNS WERE FOUND. THE AFFECTED CANOPY WAS REPLACED. THE COMPLAINT IS CLOSED WITH THIS STATEMENT. THE COMPLAINT IS CLOSED WITH THIS STATEMENT. THIS COMPLAINT WAS CLOSED WITHOUT FURTHER MEASURES. CORRECTED DATA: H10 -THE INITIAL REPORT SUBMITTED ON 2025-03-05, INCORRECTLY STATED THAT THE COMPLAINT SYSTEM, LUMINOS LOTUS MAX, IS NOT CLEARED IN THE US. THIS STATEMENT IS INCORRECT. THIS SYSTEM IS CLEARED IN THE US UNDER 510(K) K173639.

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO LUMINOS DRF MAX WHOSE 510(K) NUMBER IS K173639. H11: SIEMENS HEALTHINEERS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT AN ISSUE OCCURRED WITH A LUMINOS LOTUS MAX SYSTEM. THE USER STATED THAT THE COVERS OF THE DISPLAY CEILING SUSPENSION (DCS) AT THE CEILING PART OF THE DCS FELL OFF AND CRACKED WHEN HITTING THE FLOOR. NO INJURY WAS COMMUNICATED FOR THIS EVENT. IT IS ASSUMED THAT IN A WORST-CASE SCENARIO A MINOR TO SERIOUS INJURY MIGHT BE THE OUTCOME SHOULD THE ISSUE RECUR. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631082 LUMINOS LOTUS MAX INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 11574100 4056869269931

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown