BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YSIO

    MDR report key: 8510804 · Received April 12, 2019

    Report

    Report Number
    3002808157-2018-45705
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    August 21, 2018
    Report Date
    August 21, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    KPR
    PMA / PMN Number
    K081722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESUBMISSION OF INITIAL REPORT AS PER FDA ON 4/3/2019. THE ISSUE WAS INVESTIGATED IN DETAIL. THE PROVIDED LOG FILES SHOWED THAT THE POSITION VALUE OF THE ENCODER ON THE TUBE STAND TRANSVERSE AXIS WAS INVALID. THE MOTOR CONTROLLER INDICATED A DEFECTIVE SENSOR INTERFACE (ERROR 30). THE DEAD MAN GRIP WAS FOUND ACTIVATED DURING THE ERROR OCCURRENCE; IT IS ASSUMED THAT THE OPERATOR PRESSED THE HANDLE DURING THE INCIDENT. FREQUENCY INVERTER, ENGINE AND ROTARY ENCODER WERE REPLACED AT THE CONCERNED SITE AND RETURNED FOR INVESTIGATION. NO EXTERNAL DAMAGE OR CORROSION COULD BE FOUND. THE PARTS WERE INSTALLED ON A TEST SYSTEM. THE DESCRIBED ERROR COULD NOT BE REPRODUCED. ADDITIONALLY, SIGNAL TRANSMISSION ERRORS WERE SIMULATED AS MALFUNCTION IN THE SIGNAL CHAIN MAY HAVE CAUSED THE INCIDENT. HOWEVER, EVERY TIME THE SYSTEM WENT INTO SAFE MODE. THE DESCRIBED FAILURE CASE COULD NOT BE REPRODUCED. A FINAL STATEMENT REGARDING THE ROOT CAUSE OF THE DESCRIBED SYSTEM BEHAVIOR CANNOT BE MADE. THE SPARE PART CONSUMPTIONS OF THE CONCERNED FREQUENCY INVERTER CDF30.008 (MATERIAL NUMBER 08673548), ENGINE XY KPL (MATERIAL NUMBER 07044261) AND ROTARY ENCODER 12/13 BIT SSI (MATERIAL NUMBER 08687720) SHOW VALUES THAT ARE BELOW THE DEFINED THRESHOLD. ACCORDING TO SERVICE INFORMATION THE PROBLEM DID NOT RECUR AFTER THE MENTIONED PARTS WERE EXCHANGED.

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED ON THE YSIO UNITS WHEN THE OPERATOR PUSHED THE MOVEMENT BUTTON. THE SYSTEM WENT INTO FULL SPEED AND DID NOT STOP BEFORE IT HIT THE MECHANICAL END STOP. THERE IS NO INJURY RELATED TO THIS EVENT. THE REPORTED EVENT OCCURED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302836 YSIO STATIONARY X-RAY SYSTEM KPR SIEMENS HEALTHCARE GMBH 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other