BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER RELAX + TABLE

    MDR report key: 2852933 · Received November 6, 2012

    Report

    Report Number
    1037955-2012-00024
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    DORNIER MEDTECH SYSTEMS GMBH
    Product Code
    KQS
    PMA / PMN Number
    P840008
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER SPOKE WITH TECH ABOUT THE TABLE DRAMATICALLY DROPPING BY THE FOOT END DURING TREATMENT AND DECIDED THAT AN INSPECTION WAS NECESSARY. WITH COVERS ON, THERE WAS NO APPARENT DAMAGE TO UNIT UNTIL PRESSURE WAS PLACED ON THE FOOT ACTION AND THE TABLE GAVE LITTLE RESISTANCE. UPON REMOVING COVERS, DISCOVERED THAT THE SLIDE RAIL INTERCONNECT BRACKET WAS COCKED TO ONE SIDE, HARDWARE WAS MISSING AND TWO CONNECTING BATTENS WERE SEVERELY BENT. IN ADDITION, THE K AXIS DRIVE SHAFT WAS BENT AND THE GAS SPRINGS WERE CRACKED AT THE BALL JOINT. EACH REAR SLIDE RAIL IS SUPPOSED TO HAVE 4 BOLTS HOLDING IT TO THE INTERCONNECT BRACKET. ON ONE SIDE, THERE WERE 2 BOLTS REMAINING. ONE OF THOSE BOLTS WAS BENT AND STRIPPED WHILE THE OTHER WAS COMPLETELY BACKED OUT AND ONLY HELD UP BY THE MICRO SWITCH PLATE. ON THE OTHER SIDE, ONLY ONE BOLT WAS LEFT BUT WAS ONLY HELD UP BY THE MICRO SWITCH PLATE. NO ADDITIONAL HARDWARE WAS DISCOVERED IN THE BOTTOM OF THE UNIT, IN THE STRUCK OR BY THE DRIVERS. THE TABLE WAS INSTALLED ON 9/17/2010. THIS TABLE WAS RECENTLY PAINTED BY THE CUSTOMER. AFTER CONSULTING WITH TECH SUPPORT, IT IS UNLIKELY THAT THESE SCREWS WERE LEFT OUT DURING MANUFACTURING. THE TABLE WAS MANUFACTURED ON 7/7/2010, ALL MANUFACTURING RECORDS WERE REVIEWED AND INDICATE THAT THE PRODUCT MET ALL FINAL PRODUCT RELEASE CRITERIA AND WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES. IT IS LIKELY THAT THE SCREWS WERE REMOVED OR MISPLACED BY THE CUSTOMER DURING PAINTING OR DURING TRANSPORTATION. (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH SYSTEMS (B)(4) (THE MANUFACTURER) PER (B)(4)...

    Description of Event or Problem · 1

    SIX OF THE EIGHT CAPS SCREW THAT MOUNT THE K AXIS TO THE PT STRETCHER WERE MISSING AND NOT LOCATED WITHIN THE FRAME. THE K AXIS DRIVE SEPARATED FROM THE LINEAR BEARING GUIDE ALLOWING THE TABLE TOP TO ANGLE DOWNWARD WHEN THE PT MADE A SUDDEN AND DRASTIC MOVEMENT. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER RELAX + TABLE TABLE KQS DORNIER MEDTECH SYSTEMS GMBH K1018869 540

    Patients

    Seq Age Sex Outcome Treatment
    1 Other