BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XT RADIOGRAPHIC SUSPENSION

    MDR report key: 237650 · Received August 19, 1999

    Report

    Report Number
    MW4002556
    Event Type
    Malfunction
    Date Received
    August 19, 1999
    Date of Event
    June 8, 1999
    Report Date
    August 9, 1999
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 6/8/99, X-RAY TUBE SUSPENSION ON THE FIRST UNIT WOULD NOT ALLOW THE TUBE HEAD TO TRAVEL ALL THE WAY UP. DURING TROUBLESHOOTING, THE TUBE HEAD SUDDENLY DROPPED APPROX FIFTEEN INCHES. MORE TROUBLESHOOTING REVEALED THE CABLE MOUNT TO BOX #1 HAD BECOME DISCONNECTED. IT APPEARED THAT THIS MOUNT IS ATTACHED TO BOX #1, #2 AND #3 WITH 2 PINS THROUGH THE MOUNT INTO THE SIDE WALL OF THE BOX AND SECURED WITH AN "E" CLIP ON EACH PIN. HOWEVER, ONE PIN HOLE IN BOX #1 IS THROUGH A DOUBLE WALL PORTION OF THE BOX AND THE PIN IN THAT HOLE IS TOO SHORT FOR AN "E" CLIP TO BE INSTALLED. UNIT #2: WAS INSPECTED BY BIOMEDICAL ENGINEERING TECHS AND WAS FOUND TO BE IDENTICAL TO UNIT #1. GENERAL ELECTRIC (GE) CARES WAS CONTACTED EARLY ON 7/9/99. GE SVC TECHS ARRIVED AT 1000 HRS. TECH CALLED GE ON-LINE CENTER AND WAS TOLD GE HAD FIRST SEEN THIS PROBLEM IN 8/96 AND PRODUCTION OF THIS TYPE MOUNT (PIN & "E" CLIP WAS STOPPED ON 8/9/96). HE WAS ALSO TOLD THAT GE SAFETY HAD CHECKED THIS AND SAID THERE WAS NO SIGNIFICANT RISK. RPTR'S BIOENGINEERING DEPT DISAGREES AND CALLED GE CUSTOMER SATISFACTION TO SOLVE THIS. GE MEDICAL SYSTEMS SUPPLIED TWO XT RADIOGRAPHIC SUSPENSIONS WITH MOUNTS SECURED TO BOXES WITH THREADED DEVICES INSTEAD OF PINS AND "E" CLIPS. THESE SUSPENSION CLIPS WERE EXCHANGED FREE OF CHARGE ON 7/14/99. ACCORDING TO THE ENGINEER THE FIRM ACKNOWLEDGED TO HIM THAT THE DESIGN OF THIS SYSTEM WAS FLAWED, ACCOUNTING FOR THE INCIDENT, AND THE FIRM HAS SINCE REVERTED TO THEIR ORIGINAL MEANS OF FASTENING THE UNIT. RPTR'S QUALITY ASSURANCE ALERT - THE FOLLOWING ACTIONS ARE REQUIRED: A. FORWARD THIS ALERT TO THOSE COMMANDS OWNING PRE-1997 GE X-RAY EQUIPMENT THAT MAY HAVE THE DEFICIENT PIN AND "E" CLIP DESIGN ON THEIR XT RADIOGRAPHIC SUSPENSIONS. B. ALL PRE-1997 GE X-RAY EQUIPMENT WITH XT RADIOGRAPHIC SUSPENSIONS SHOULD BE USED WITH CAUTION TO PREVENT INJURY TO THE TECHNOLOGIST PRIOR TO INSPECTION. C. PERFORM AN INSPECTION WITHIN 30 DAYS OF ALL GE T3480G SUSPENSIONS MANUFACTURED BEFORE 8/96 FOR CABLE MOUNT SECURITY. D. CONTACT GE CUSTOMER SVC WITHIN 15 DAYS OF INSPECTION FOR REPLACEMENT OF ALL DEFECTIVE GE T3480G SUSPENSIONS. E. REQUEST THAT COMMANDS HAVING THE GE SUSPENSION WITH THE PIN AND "E" CLIP DESIGN CONTACT THE POINT OF CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XT RADIOGRAPHIC SUSPENSION RADIOGRAPHIC SUSPENSION IYB GENERAL ELECTRIC MEDICAL SYSTEMS 2102424 NI
    2 XT RADIOGRAPHIC SUSPENSION RADIOGRAPHIC SUSPENSION IYB GENERAL ELECTRIC MEDICAL SYSTEMS 2102424 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other