BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGR COLUMN 360N

    MDR report key: 933085 · Received April 11, 2007

    Report

    Report Number
    2126677-2007-00009
    Event Type
    Malfunction
    Date Received
    April 11, 2007
    Date of Event
    April 3, 2007
    Report Date
    April 11, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS REVIEWED BY A GE FIELD ENGINEER AT THE SITE. THERE ARE SIX BOLTS THAT HOLD THE COLUMN UPRIGHT, TWO MISSING, THREE WERE LOOSE. THE SYSTEM WAS TAKEN OUT OF SVC BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE COLUMN BECAME LOOSE AND FELL IMPACTING THE HEALTHCARE PROVIDER USING THE EQUIPMENT. THE AFFECTED PERSON REC'D SOME ABRASIONS FROM THE INCIDENT. A SERIOUS INJURY MAY RESULT IF THE COLUMN WERE TO FALL ON TOP OF A PERSON, WHICH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CGR COLUMN 360N X-RAY KPR GE MEDICAL SYSTEMS, LLC 10695A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR