BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUPITER SM OPERATING TABLE

    MDR report key: 5037543 · Received August 27, 2015

    Report

    Report Number
    9681407-2015-00009
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 4, 2015
    Manufacturer
    TRUMPF MEDIZIN SYSTEME GMBH + CO. HG
    Product Code
    FWX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INVESTIGATION, THE CAUSE OF THE TABLE RUNNING ON ITS OWN WAS DAMAGE TO THE KEYPAD IN THE REMOTE. THIS ISSUE IS DEALT WITH IN THE ONGOING FSCA ((B)(4)). THE KEYPAD USED WAS PRIOR TO THE DESIGN CHANGE. TRUMPF MEDICAL HAS ISSUED SAFETY INSTRUCTIONS TO THE USERS IN THE FIELD SAFETY NOTICE AND THOSE SHOULD BE FOLLOWED UNTIL TRUMPF MEDICAL IS ABLE TO DO THE FINAL EXCHANGE. THE OPERATION TABLE AND THE REMOTE CONTROL WERE CHECKED BY SERVICE AND REPAIRED. ANTICIPATED COMPLETION OF THE FSCA IS JULY 2016.

    Description of Event or Problem · 1

    TRUMPF MEDICAL RECEIVED INFORMATION STATING THAT A JUPITER OR TRUSYSTEM 7500 OPERATING TABLE MOVED INDEPENDENTLY AND WITHOUT THE USER DELIBERATELY PRESSING AN OPERATING ELEMENT. NO PATIENTS OR USERS WERE INJURED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570597 JUPITER SM OPERATING TABLE BATTERY POWERED ELECTROMECHANICAL OPERATING TABLE FWX TRUMPF MEDIZIN SYSTEME GMBH + CO. HG 4003171

    Patients

    Seq Age Sex Outcome Treatment
    1