BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRILLIANCE 16 AIR

    MDR report key: 4742656 · Received April 28, 2015

    Report

    Report Number
    1525965-2015-00117
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Report Date
    March 31, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K012009
    Removal / Correction Number
    1525965-04/08/14-005-C
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, THE CUSTOMER, OGH IMAGING LLC-LA, ALLEGED THAT, DURING LOADING OF THE PT, THE PT TABLE UNDER MAIN TABLE IS FREE FLOATING, FOR BR 16 AIR 728246. THERE WAS NO REPORT OF ANY HARM TO THE OPERATOR, PT OR BYSTANDER DURING THE INCIDENT. THE CUSTOMER CONTACTED THE PHILIPS HELP DESK TO INFORM THEM OF THE ISSUE. THE PHILIPS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE FSE ARRIVED AT THE SITE AND EVALUATED THE SYSTEM. FSE DETERMINED THAT THE SERVICE LATCH WAS NOT ENGAGED AND REPLACED THE OLD LATCH WITH A THROUGH BOLT TYPE, TO RESOLVE THE ISSUE. PER FSE, A PROBABLE ROOT CAUSE OF THE LOOSE SERVICE LATCH WAS DUE TO THE LATCH NOT ENGAGED AT LAST VISIT OR LATCH WAS ENGAGED BUT DID NOT LATCH INTO POSITON. NO OTHER SERVICE LATCH COMPLAINTS HAVE BEEN RECEIVED FROM THE CUSTOMER AFTER THE SERVICE LATCH WAS REPLACED. AFTER THE FSE'S SERVICE, MECHANICAL CHECK WAS PERFORMED AFTER NEW TYPE LATCH WAS INSTALLED AND THE SYSTEM IS WORKING AS SPECIFIED. WHEN THE SERVICE LATCH DISENGAGES, THE COUCH SUBFRAME WILL FREE FLOAT AND MAY MOVE AWAY FROM THE GANTRY DURING MANUAL MOVEMENT OF THE TABLE TOP, WHICH MAY RESULT IN PINCHING, ENTRAPMENT, OR REMOVAL OF MEDICAL TUBING (I.E. PATIENT IV, VENTILATOR, ETC.) THE PRODUCT SAFETY COMMITTEE BINDER (PSC) INCLUDES INFORMATION RELATED THE CORRECTION AND REMOVAL DOCUMENTS FOR THIS ISSUE INCLUDING FIELD SAFETY NOTIFICATION (FSN 72800614) THAT WAS SENT TO THE FIELD ON 08-APR-2014 STATING THAT: IF THE CUSTOMER EXPERIENCES A HORIZONTAL, FREE-FLOATING COUCH MOTION, THEY HAVE TO CONTACT THEIR FIELD SERVICE ENGINEER IMMEDIATELY. A COPY OF THIS FIELD SAFETY NOTICE HAS TO BE RETAINED WITH THE EQUIPMENT INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, THE SERVICE MANUAL IS BEING REVISED TO PROVIDE MORE ROBUST INSTRUCTIONS ON HOW TO SERVICE THE PATIENT SUPPORT. THE SERVICE MANUAL CHANGES ARE INTERNAL PHILIPS DOCUMENTS. PER FSE, A PROBABLE CAUSE OF THE LOOSE SERVICE LATCH WAS DUE TO THE LATCH NOT ENGAGED AT LAST VISIT OR LATCH WAS ENGAGED BUT DID NOT LATCH INTO POSITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PART OF THE PT TABLE UNDER THE MAIN TABLE TOP WAS FREE FLOATING. THE PHILIPS FILED SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO THE PT, OPERATOR, OR BYSTANDER. THE FSE WAS INFORMED THAT THE CUSTOMER DISCOVERED THE CT TABLE TOP WAS NOT SECURE WHILE THE CT SYSTEM WAS NOT IN CLINICAL USE. THE FSE REPLACED THE TABLE LOCK AND INFORMED THE CUSTOMER OF THE REPLACED PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277395 BRILLIANCE 16 AIR COMPUTED TOMOGRAPHY X-RAY JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728246

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly