BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT9000 BASIC SYSTEM

    MDR report key: 1112781 · Received August 12, 2008

    Report

    Report Number
    1518293-2008-00260
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    LIEBEL - FLARSHEIM CO
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MFG REPORT: FIELD SERVICE ENGINEER FOUND THE COLLAR ON THE MCMAHON SUSPENSION SYSTEM WHICH HOLDS THE J-BOW INTO PLACE ON THE SUSPENSION ARM HAD THE COLLAR RETAINING SCREW LOOSE, WHICH CAUSED THE COLLAR TO SLIDE UPWARDS CAUSING THE BRASS RETAINING CLIP TO FALL OUT. THIS RESULTED IN THE SEPARATION OF THE J-BOW FROM THE SUSPENSION ARM. THE J-BOW/POWER HEAD DID NOT HIT THE FLOOR OR FALL FAR AS THE SAFETY CABLE HELD THE J-BOW/INJECTOR TO THE SUSPENSION ARM. THE SAFETY CABLE FUNCTIONED AS DESIGNED. THE BRASS KEY WAS REINSERTED BACK INTO PLACE AND THE COLLAR SCREW WAS TIGHTENED. THE UNIT WAS RETURNED TO FULL SERVICE BY THE CUSTOMER. THE DOMESTIC DISTRIBUTOR, MCMAHON (ONE ZONE) WAS NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    IN 2004: CUSTOMER REPORTS THAT TECHNOLOGIST WAS MOVING INJECTOR AROUND ROOM IN PREPARATION OF PENDING PT WHEN J-BOW FAILED, ALLOWING ARM TO FALL. THE J-BOW SAFETY STRAP KEPT THE INJECTOR FROM FALLING COMPLETELY ONTO THE FLOOR. NO PT OR STAFF INJURIES. POTENTIAL FOR INJURY EXISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT9000 BASIC SYSTEM CT POWER INJECTOR SYSTEM DXT LIEBEL - FLARSHEIM CO CT9000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK