BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM LUMINOS TF

    MDR report key: 14052416 · Received April 8, 2022

    Report

    Report Number
    3004977335-2022-23179
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Date of Event
    April 4, 2022
    Report Date
    August 1, 2022
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAA
    PMA / PMN Number
    K051602
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS LOCAL SERVICE ENGINEER WAS DISPATCHED TO THE CONCERNED SITE TO INSPECT THE UNIT. THE ENGINEER WAS ABLE TO GET THE SPOT FILM DEVICE BACK ON TRACK AND LEVEL. INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. INTERNAL ID # (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INVESTIGATED IN DETAIL. THE INVESTIGATION SHOWED THAT THE ISSUE WAS CAUSED BY OPERATOR. WHEN THE OPERATOR TILTED THE TABLE DOWN, THE DIT (DIGITAL IMAGE TOWER) COLLIDED WITH A MONITOR CART. DUE TO THIS COLLISION THE GUIDE ROLLS OF THE DIT CARRIAGE WERE FORCED OFF THE TRACKS AND THE SFD (SPOT FILM DEVICE) WAS NO LONGER LEVEL. ACCORDING TO THE INFORMATION RECEIVED THE SYSTEM WAS REPAIRED BY THE LOCAL SERVICE ORGANIZATION AND IS FULLY OPERATIONAL AGAIN. IT IS IN THE RESPONSIBILITY OF THE OPERATOR TO MAKE SURE THAT THERE ARE NO OBJECTS IN THE WAY WHEN THE SYSTEM IS MOVED. THIS IS ALSO DOCUMENTED IN THE SYSTEM OPERATOR MANUAL (AXD1-300.620.01.01.02, PAGE 61). SINCE NO SYSTEM MALFUNCTION WAS IDENTIFIED THE COMPLAINT IS CLOSED WITHOUT FURTHER MEASURES. INTERNAL ID# (B)(4).

    Description of Event or Problem · 0

    LUMINOS TF UNIT WAS DAMAGED WHEN THE USER TILTED DIGITAL IMAGING TOWER (DIT) ONTO A MONITOR CART. DUE TO THE COLLISION OF THE TOWER WITH THE MONITOR CART, THE GUIDE ROLLS OF THE CARRIAGE WENT OFF THE TRACKS AND IT WAS NO LONGER POSSIBLE TO LEVEL THE SPOT FILM DEVICE (SFD). THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED CASE. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188224 AXIOM LUMINOS TF IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM JAA SIEMENS HEALTHCARE GMBH 10093902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other