BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMX 4 PLUS

    MDR report key: 1001253 · Received February 22, 2008

    Report

    Report Number
    2126677-2008-00012
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZL
    PMA / PMN Number
    K021016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FILED ENGINEER (FE) EVALUATED THE SYS AND FOUND A MISSING COLLIMATOR SCREW. THE FE REPLACED THE MISSING SCREW, TIGHTENED THE COLLIMATOR BRACKET, AND RETURNED THE PROD BACK TO SVC. PROPER PREVENTATIVE MAINTENANCE IS CURRENTLY IN PLACE PER THE GE PREVENTATIVE MAINTENANCE MANUAL TO DETECT THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COLLIMATOR WAS LOOSE. THERE WAS NEITHER INJURY REPORTED NOR PT INVOLVEMENT. THE CONCERN WAS FOR A SERIOUS INJURY IF THE COLLIMATOR WERE TO FALL ON A PT OR AN OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMX 4 PLUS IZL GE MEDICAL SYSTEMS, LLC 2275938-7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA