BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX EPIC MCD

    MDR report key: 2459290 · Received February 14, 2012

    Report

    Report Number
    2916556-2012-00005
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 3, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC
    Product Code
    KPS
    PMA / PMN Number
    K952684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DID NOT RESULT FROM A DEVICE MALFUNCTION AND THE DEVICE DID NOT REQUIRE SERVICE AFTER THE INCIDENT. THE CABLES WERE INTACT AND IN FULL VIEW. A PHOTOGRAPH OF THE SYSTEM/ROOM WAS PROVIDED TO THE MANUFACTURER TO HELP WITH THE ANALYSIS/INVESTIGATION. IT WAS REPORTED THAT THE DOCTOR STUMBLED WHILE THE CAMERA WAS STILL, NO PATIENT WAS ON THE SYSTEM AND NO PATIENT EXAMINATION WAS BEING PERFORMED AT THE TIME OF THE INCIDENT. THE FOLLOWING STATEMENTS APPEAR IN THE CARDIO, SOLUS, VERTEX, VERTEX PLUS WITH ATLAS USER'S P/N 9201 0227E ENG REV A, MANUAL: "ADAC NUCLEAR MEDICINE IMAGING SYSTEMS SHOULD ONLY BE OPERATED BY PROFESSIONALS TRAINED IN THE USE OF ADAC NUCLEAR MEDICINE EQUIPMENT. IMPROPER USE OF AN ADAC NUCLEAR MEDICINE CAMERA SYSTEM MAY RESULT IN PATIENT OR OPERATOR INJURY, INACCURATE PATIENT IMAGES, OR EQUIPMENT DAMAGE." "POSITION ELECTRICAL CORDS AND CABLES FOR THE GANTRY, TABLE, AND PERIPHERAL DEVICES IN LOCATIONS WHERE THEY WILL NOT BE STEPPED ON, PULLED, OR RUN OVER BY THE COLLIMATOR STORAGE CABINET." A LABEL IS PRESENT ON THE GANTRY REGARDING FOOT PLACEMENT. THE LABEL READS: "CAUTION: GANTRY MOVES WATCH FOOT PLACEMENT AND THE LOCATION IS AT THE BOTTOM OF GANTRY ON HEAD END SIDE, AND FOOT END SIDE." (B)(4).

    Description of Event or Problem · 1

    PHILIPS FIELD SERVICE ENGINEER (FSE) WAS ASKED BY THE HOSPITAL TO HELP MOVE A CABINET THAT CONTAINED THE VERTEX V60 CAMERA SYSTEM'S MANUAL AS WELL ANOTHER MATERIALS FROM THE SYSTEM ROOM TO ANOTHER ROOM WITHIN THE DEPARTMENT. THE SITE WAS NOT PERFORMING ANY SCANS AT THE TIME OF THE REPORTED INCIDENT TOOK PLACE AT THE SITE. THE DOCTOR WAS STANDING TO THE RIGHT AT THE BACK OF THE GANTRY WHERE THE TWO MAIN CABLES ARE LOCATED ON THE VERTEX (V60) CAMERA. THE DOCTOR STUMBLED OVER ONE OF THE TWO MAIN CABLES AND FELL TOWARDS THE FLOOR. SHE BROKE HER LEFT LEG (HER LEFT TIBIA AND ANKLE) AND UNDERWENT SURGERY TO REPAIR THE FRACTURE AND HAS BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX EPIC MCD KPS PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC 2154-3009B 9712009

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization