BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YSIO MAX

    MDR report key: 4517313 · Received February 11, 2015

    Report

    Report Number
    2240869-2015-00429
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Date of Event
    January 20, 2015
    Report Date
    January 20, 2015
    Manufacturer
    SIEMENS AG
    Product Code
    KPR
    PMA / PMN Number
    K133259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS UNDER INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION HAS BEEN RECEIVED. THIS REPORT WAS SUBMITTED FEBRUARY 10, 2015.

    Description of Event or Problem · 1

    (B)(6) 2015, SIEMENS WAS INFORMED THAT A STOOL, LOCATED UNDERNEATH THE TABLE OF THE YSIO MAX SYSTEM, GOT JAMMED BY THE OGP DRIVE. THE TABLE COULD NOT BE MOVED AND THE CUSTOMER HAD TO USE FORCE TO MOVE THE TABLE UPWARDS TO REMOVE THE STOOL FORM THE COLLISION ZONE. NO PATIENT WAS PRESENT ON THE EXAM ROOM DURING THE EVENT. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE FUNCTIONS OF THE TABLE WERE REESTABLISHED BY SIEMENS LOCAL SERVICE ON THE SAME DAY. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101211 YSIO MAX STATIONARY X-RAY SYSTEM KPR SIEMENS AG 10762470 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other