BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTSPEED HP60

    MDR report key: 1111609 · Received August 13, 2008

    Report

    Report Number
    9612283-2008-00001
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    Manufacturer
    GE YOKOGAWA MEDICAL SYSTEMS
    Product Code
    JAK
    PMA / PMN Number
    K030420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) INSPECTED THE MOBILE UNIT, AND FOUND THE SIDE COVERS TO BE WARPED. AN INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE SITE REPORTED THAT THE GANTRY'S SIDE COVERS FELL OFF DURING A TUBE WARM-UP/FAST CAL. THE LEFT TOP COVER THAT WAS SECURED BY THE SIDE COVERS SUBSEQUENTLY SLID DOWNWARDS IN BETWEEN THE FRONT AND REAR COVERS. THE SLIDING TOP COVER WAS THEN HIT BY THE ROTATING GANTRY, CAUSING THE COVER TO BE PROJECTED RADIALLY OUTWARDS TOWARD THE SIDE WALL OF THE MOBILE UNIT. NO ONE WAS IN THE SCAN ROOM OF THE MOBILE UNIT WHEN THE INCIDENT OCCURRED. THERE WAS NO INJURY REPORTED. THE CONCERN IS A SERIOUS INJURY MAY OCCUR, IF THE INCIDENT WAS TO RECUR, AND THE COVER CONTACTED A PATIENT OR AN OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED HP60 JAK GE YOKOGAWA MEDICAL SYSTEMS 2378661-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA