BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YSIO

    MDR report key: 5112167 · Received September 29, 2015

    Report

    Report Number
    2240869-2015-04830
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 4, 2015
    Manufacturer
    SIEMENS GMBH
    Product Code
    KPR
    PMA / PMN Number
    K081722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS ASSUMED THAT THE INCIDENT OCCURRED DUE TO AN OPERATOR ERROR. SIEMENS REQUESTED ADDITIONAL INFORMATION AND PHOTOS TO PROCEED WITH INVESTIGATION. THIS REPORT WAS SUBMITTED (B)(4) 2015. (B)(6).

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF AN INCIDENT ON THE YSIO X-RAY SYSTEM IN THE (B)(6). A FEMALE PATIENT CAME TO THE FACILITY FOR AN X-RAY EXAMINATION OF HER WRIST. THE PATIENT WAS PLACED IN A SEATED POSITION AT THE END OF THE TABLE OF THE YSIO UNIT WITH HER LEGS UNDERNEATH THE TABLE AND HER HAND AND WRIST ON THE TABLETOP. THE OPERATOR ACCIDENTALLY INITIATED TABLE MOVEMENT BY PRESSING "TABLE DOWN" SWITCH SIMULTANEOUSLY PUSHING THE BREAK RELEASE FOOT SWITCH. THE INTENTION OF THE OPERATOR WAS TO ONLY RELEASE THE BREAKS IN ORDER TO ADJUST THE FLOATING TABLE TOP. THE TABLE TOP STARTED TO MOVE DOWN ONTO THE PATIENT'S LEGS PRESSING ON HER RIGHT LEG. THE OPERATOR WAS ABLE TO STOP THE SYSTEM MOVEMENT AND RELEASE THE PATIENT. THE PATIENT REPORTED MUSCLE DAMAGE AS A RESULT OF THE INCIDENT AND SEEKED MEDICAL ATTENTION DUE TO PAIN AND STRUGGLE TO WALK. THE EXTENT OF THE INJURY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642910 YSIO STATIONARY X-RAY SYSTEM KPR SIEMENS GMBH 10281013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other