BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPAX 40E

    MDR report key: 1346910 · Received March 19, 2009

    Report

    Report Number
    2126677-2009-00019
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    February 21, 2009
    Report Date
    February 23, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEERS (FE) WERE DISPATCHED TO THE SITE AND EVALUATED THE SYSTEM. THE FES FOUND 3 MISSING INTERFACE SCREWS. THE SCREWS WERE THEN INSTALLED. THE FES VERIFIED THAT THE REPORTED CONDITION WAS FIXED. FURTHER INVESTIGATION REVEALED THAT THE SITE IS NOT UNDER A GE SERVICE CONTRACT. GE PERFORMED THE LAST PREVENTATIVE MAINTENANCE 1 YEAR PRIOR TO THE INCIDENT. IN 2008, GE REPLACED THE TUBE. HOWEVER, THERE WAS NO RECORD THAT THE SITE REQUESTED FOR THE 6-MONTH PREVENTATIVE MAINTENANCE SERVICE FROM GE AS REQUIRED AFTER THE REPLACEMENT. ADDITIONALLY, IT WAS REPORTED THAT THE SITE HAD DAMAGED THE COLLIMATOR LATER IN THE YEAR. GE PROVIDED A QUOTE FOR A NEW COLLIMATOR BUT THE SITE DECIDED TO TAPE THE DAMAGED PART. NO FURTHER INFORMATION WAS RECEIVED FROM THE SITE REGARDING HOW THE COLLIMATOR WAS IMPACTED AFTER THEY HAD FIXED THE DAMAGED PART. MULTIPLE ATTEMPTS WERE MADE BY GE TO OBTAIN PATIENT INFORMATION. NO RESPONSE HAS BEEN RECEIVED FROM THE SITE.

    Description of Event or Problem · 1

    DURING A ROUTINE EXAM, A SITE TECHNOLOGIST WAS POSITIONING THE COLLIMATOR OVER A PATIENT WHEN THE COLLIMATOR FELL AND CONTACTED THE PATIENT'S FACE. ACCORDING TO THE SITE, THE PATIENT REQUIRED 15 STITCHES ON HIS FACE. A CT SCAN WAS PERFORMED ON THE PATIENT, AND FOUND NO SKELETAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC 45435245 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention