BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MX8000 IDT

    MDR report key: 3392996 · Received September 17, 2013

    Report

    Report Number
    1525965-2013-00264
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Report Date
    March 2, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AS A RESULT OF A RETROSPECTIVE REVIEW OF PHILIPS HEALTHCARE COMPLAINTS BACK TO (B)(4) OF 2007. PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND THE ERROR LOGS AND DETERMINED THAT THE PROBLEM COULD HAVE BEEN CAUSED BY A FAULTY SPINDLE BREAK. THE FSE REPLACED THE SPINDLE BREAK AND MONITORED THE SYSTEM AT THE CUSTOMER SITE. THE FSE TESTED THE SYSTEM WITH 400LBS OF WEIGHTS DISTRIBUTED EVENLY ON THE PT TABLE; HE RAN THE TABLE UP AND DOWN MANY TIMES. AN ADJUSTED THE SPINDLE BREAK ACCORDINGLY. THERE WERE NO FURTHER OCCURRENCES OF THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED INFO FROM A CUSTOMER SITE THAT WHILE LOWERING THE PT TABLE FOLLOWING A MX8000 IDT CT SCAN ON A LARGE PT, THE PT TABLE DROPPED UNEXPECTEDLY ABOUT 18 INCHES. THE PT WAS REPORTED TO HAVE BEEN JOSTLED, BUT NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468779 MX8000 IDT JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1