BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABAQUE525 C/TV CGR COLUMN PT360

    MDR report key: 587408 · Received March 28, 2005

    Report

    Report Number
    9611343-2005-00011
    Event Type
    Malfunction
    Date Received
    March 28, 2005
    Date of Event
    August 31, 2004
    Report Date
    March 28, 2005
    Manufacturer
    GE MEDICAL SYSTEMS S.C.S.
    Product Code
    KPR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE STEEL CABLE BROKE ON THE CGR PT360 COLUMN, THE SAFETY DEVICE "THE PARACHUTE" DIDN'T WORK AND THE X-RAY TUBE FELL TO THE FLOOR. THE HCP REPORTED A MINOR BACK INJURY FROM TRYING TO BREAK THE FALL OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABAQUE525 C/TV CGR COLUMN PT360 DIAGNOSTIC X-RAY KPR GE MEDICAL SYSTEMS S.C.S. PT360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other