BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YSIO

    MDR report key: 8514016 · Received April 15, 2019

    Report

    Report Number
    3002808157-2019-76261
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    March 26, 2019
    Report Date
    April 1, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    KPR
    PMA / PMN Number
    K081722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DESCRIBED ISSUE WAS EXAMINED. NO MALFUNCTION OR FAILURE OF THE SYSTEM WAS IDENTIFIED. THE ANALYSIS OF THE LOGFILES DID NOT INDICATE ANY UNINTENTIONAL OR UNUSUAL MOVEMENT. THERE WERE TWO EVENTS IN WHICH A MOTORIZED MOVEMENT OF THE AFFECTED AXIS WAS ACTIVE AROUND THE INDICATED TIME OF THE INCIDENT. FOR BOTH MOVEMENTS THE DEAD MAN GRIP (DMG) WAS ACTIVATED BY THE USER. MOTORIZED MOVEMENT IS ONLY TRIGGERED IF THE TWO SIGNALS (DMG AND MOTION REQUEST) ARE APPLIED TO THE MOTOR CONTROLLER AT THE SAME TIME. THUS, BOTH MOVEMENTS WERE INITIATED INTENTIONALLY BY THE OPERATOR. THE LOG FILES ALSO SHOW AN OPERATION OF THE ORGAN PROGRAM (OGP) DRIVE FUNCTION. THIS FUNCTION AUTOMATICALLY MOVES THE SYSTEM TO A DEFINED STARTING POSITION, ACCORDING TO THE SELECTED OGP. THIS MAY HAVE BEEN INTERPRETED AS AN UNINTENDED MOVEMENT BY THE OPERATOR. DURING INVESTIGATION IT WAS IDENTIFIED THAT THE 3D FORCE SENSOR WAS DEFECTIVE. HOWEVER, THIS PART IS NOT RELEVANT FOR THE DESCRIBED ISSUE. THE FORCE SENSOR WAS REPLACED ON SITE BY LOCAL SERVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    SIEMENS WAS INFORMED OF UNINTENDED SYSTEM MOVEMENT OF THE YSIO UNIT. THE X-RAY TUBE WAS NOT IN THE LOCKED POSITION AND IT JERKED BACK HITTING A WHEELCHAIR. THERE WAS NO PERSON ON THE WHEELCHAIR. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308426 YSIO STATIONARY X-RAY SYSTEM KPR SIEMENS HEALTHCARE GMBH 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other