BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRI

    MDR report key: 2314393 · Received October 25, 2011

    Report

    Report Number
    9613299-2011-00006
    Event Type
    Injury
    Date Received
    October 25, 2011
    Date of Event
    September 26, 2011
    Report Date
    October 25, 2011
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K051855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED FROM A FINGER INJURY WHILE BEING RELEASED OUT OF A VENTRI SYSTEM ON ACQUISITION COMPLETION. THE PATIENT, WHO WAS LYING IN SUPINE POSITION (ON HEADREST ACCESSORY) WITH HANDS BEHIND THE HEAD, SUDDENLY SHIFTED THEM TO HER BODY SIDES DURING TABLE LONGITUDINAL MOTION AND HER RIGHT MIDDLE FINGERNAIL GOT PINCHED BETWEEN THE STRETCHER AND TABLE FRONT COVER AT THE SPOT WHERE THE PINCH POINT WARNING LABELS ARE LOCATED. THE OPERATOR, WHO WAS IN THE ROOM AND OBSERVING THE WHOLE TIME, IMMEDIATELY STOPPED THE AUTOMATIC MOVEMENT USING THE REMOTE CONTROL UNIT (RCU). THE PATIENT WAS SENT TO THE SITE EMERGENCY ROOM FOR TREATMENT, WHICH CONSISTED OF REMOVAL OF 1/2 RIGHT HAND MIDDLE FINGERNAIL AND A FINGER BANDAGE. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRI COMPUTED TOMOGRAPHY SYSTEM KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING ASM001605

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other