BEUDAMED
    FDA Adverse Event Death Summary report: N

    MX 8000

    MDR report key: 5197526 · Received November 3, 2015

    Report

    Report Number
    1525965-2015-00277
    Event Type
    Death
    Date Received
    November 3, 2015
    Report Date
    October 19, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K010817
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 19-OCT-2015, THE CHIEF EXECUTIVE OFFICER (CEO) OF (B)(4), A THIRD PARTY SERVICE PROVIDER, CONTACTED PHILIPS TO REPORT THAT A (B)(6)-YEAR OLD MALE, (B)(4) FIELD SERVICE ENGINEER (FSE) HAD DIED WHILE PERFORMING SERVICE ON THE MX8000 EXP CT SYSTEM. (B)(4) CONFIRMED THAT THE FSE INITIALLY ATTENDED THE SITE TO REPAIR THE COMPUTER VIDEO CARD. AFTER COMPLETION OF THE COMPUTER VIDEO CARD REPAIR, THE FSE BEGAN TO SERVICE THE PATIENT SUPPORT OF THE MX8000 EXP CT SYSTEM. (B)(4) CONFIRMED THAT THE FSE DID NOT INSTALL THE GREEN VERTICAL SAFETY SUPPORT BAR BEFORE BEGINNING TO REMOVE THE VERTICAL MOTOR OF THE PATIENT SUPPORT. AS THE FSE REMOVED THE 4TH BOLT OF THE VERTICAL MOTOR, THE PATIENT SUPPORT COLLAPSED. (B)(4) REPORTED THAT THE FSE WAS STRUCK IN THE NECK BY THE COUCH COVERS AND HE DIED OF ASPHYXIA. ON 10-NOV-2016, THE SYSTEM WAS FULLY REPAIRED BY A PHILIPS SENIOR FIELD SERVICE ENGINEER. THE FIELD SERVICE ENGINEER REPLACED THE TABLES O-RING AND DISASSEMBLED THE MOTOR. HE CLEANED, LUBRICATED, AND THEN ADJUSTED THE BEARINGS OF THE TABLE'S LEAD SCREW. HE PERFORMED AIR CALIBRATION AND CONFIRMED THE SYSTEM WAS IN WORKING ORDER. FINALLY, PREVENTATIVE MAINTENANCE WAS DONE AND NO ERRORS APPEARED. THE SYSTEM IS CURRENTLY IN CLINICAL USE AND WORKING AS DESIGNED. THE SYSTEM WAS FULLY REPAIRED BY A PHILIPS SENIOR FIELD SERVICE ENGINEER. THE (B)(4) FSE FAILED TO USE THE GREEN VERTICAL SAFETY BAR WHEN SERVICING THE TABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL CROSS REFERENCE: COMPLAINT (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE (B)(6) OF IPS, A THIRD PARTY SERVICE PROVIDER, CONTACTED PHILIPS TO REPORT THAT A (B)(6) MALE, IPS FIELD SERVICE ENGINEER (FSE) HAD DIED WHILE PERFORMING SERVICE ON THE (B)(4) EXP CT SYSTEM AT (B)(6) HOSPITAL IN (B)(6). IPS CONFIRMED THAT THE FSE INITIALLY ATTENDED THE SITE TO REPAIR THE COMPUTER VIDEO CARD. AFTER COMPLETION OF THE COMPUTER VIDEO CARD REPAIR, THE FSE BEGAN TO SERVICE THE PATIENT SUPPORT OF THE (B)(4) EXP. IPS CONFIRMED THAT THE FSE DID NOT INSTALL THE GREEN VERTICAL SAFETY SUPPORT BAR BEFORE BEGINNING TO REMOVE THE VERTICAL MOTOR OF THE PATIENT SUPPORT. AS THE FSE REMOVED THE 4TH BOLT OF THE VERTICAL MOTOR, THE PATIENT SUPPORT COLLAPSED. IPS REPORTED THAT THE FSE WAS STRUCK IN THE NECK BY THE COUCH COVERS. IPS REPORTED THAT THE FSE DIED OF ASPHYXIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727333 MX 8000 COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728130

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death