BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINOS AGILE

    MDR report key: 4802416 · Received May 26, 2015

    Report

    Report Number
    2240869-2015-12031
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    JAA
    PMA / PMN Number
    K111292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FOOTBOARD WAS REQUESTED FOR FURTHER INVESTIGATION. THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED. THIS REPORT WAS SUBMITTED (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED FOOTREST SHOWED BREAKAGE OF THE STEERING RAIL. THIS BREAKAGE HAS NO SAFETY RELATED IMPACT ON THE ATTACHMENT OF THE FOOTREST AND ITS HALT. IT IS ASSUMED THAT THE BREAKAGE IN THE RAIL WAS CAUSED BY AN IMPROPERLY ATTACHED FOOTREST AND FOLLOWING TILTING. THE DETENT AND THE BOLTS OF THE FOOTREST ARE COMPLETELY FUNCTIONAL. MOREOVER ALL SAFETY MARKS ARE VISIBLE. THEREFORE THE INVESTIGATED PART DID NOT SHOW ANY DEFECTS REGARDING FUNCTIONALITY AND RELIABILITY OF THE FOOTREST. IT IS ASSUMED, THAT THE FOOTREST FELL OFF BECAUSE IT WAS NOT PROPERLY ATTACHED BY THE USER. CORRECT ATTACHMENT OF THE FOOTREST IS DESCRIBED IN THE OPERATOR MANUAL XPD1-320.620.01.02.02, CHAPTER 8, PAGES 73 AND 74. THE FOOTREST WAS REPLACED AT THE CONCERNED CUSTOMER SITE. THIS REPORT WAS SUBMITTED APRIL 1, 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOOTBOARD OF THE LUMINOS AGILE SYSTEM BECAME LOOSE DURING THE EXAM. THE TABLE WAS TILTED TO APPROXIMATELY 30 DEGREES WITH A PATIENT STANDING ON THE FOOTBOARD WHEN IT BECAME DISLODGED AND THE PATIENT SLID OFF. NO INJURIES WERE SUSTAINED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340003 LUMINOS AGILE SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-I JAA SIEMENS MEDICAL SOLUTIONS USA, INC. 10502200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other