BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 4900195 · Received July 8, 2015

    Report

    Report Number
    1525965-2015-00192
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 12, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NOTE: WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2015, THE CUSTOMER, (B)(6), REPORTED THAT THE PATIENT COUCH SLIDES A LOT DUE TO THE SERVICE SWITCH (LATCH) BEING DISENGAGED. IT WAS REPORTED THAT THE EVENT DID NOT OCCUR DURING CLINICAL USE. THERE WAS NO REPORT OF ANY HARM TO THE OPERATOR, PATIENT OR BYSTANDER DURING THE INCIDENT. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE TABLE WAS MOVING ABOUT 10CM AND IT WAS NOT POSSIBLE TO SCAN. IT WAS DISCOVERED THAT PLANNED MAINTENANCE WAS PERFORMED THE DAY BEFORE AND THE FSE DID NOT LOCK THE SERVICE LATCH. THE FSE RE-SECURED THE SERVICE LATCH TO RESOLVE THE ISSUE. NO OTHER SERVICE LATCH COMPLAINTS HAVE BEEN RECEIVED FROM THE CUSTOMER AFTER THE SERVICE LATCH WAS RE-SECURED. CT ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK. IF THIS MALFUNCTION WERE TO RECUR AND THE SUB-FRAME SERVICE LATCH WERE TO BECOME DISENGAGED AFTER SERVICING, PRIOR TO A PATIENT PROCEDURE, OR DURING A PATIENT PROCEDURE, IT WOULD BE NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. BASED ON THE RISK BENEFIT ANALYSIS, TRENDING OF THE COMPLAINT RECORDS AND A CLINICAL EVALUATION BY A MEDICAL PHYSICIAN, IT HAS BEEN DETERMINED THAT SERVICE LATCH FAILURES DO NOT MEET THE DEFINITION OF A MEDICAL DEVICE REPORT. THERE IS NO EVIDENCE THAT THE SERVICE LATCH FAILURE HAS RESULTED IN A SERIOUS INJURY OR DEATH OR COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IF THE MALFUNCTION WERE TO RECUR. THE FOLLOWING MITIGATIONS FOR THIS ISSUE INCLUDE: ¿SERVICE PERSONNEL ARE TRAINED TO ENGAGE THE SERVICE LATCH PROPERLY DURING ANY SERVICE ACTIVITIES THAT REQUIRE OPENING OF THE GANTRY FRONT COVER. ¿FLOATING TABLE CAN BE DETECTED BY TRAINED PERSONNEL DURING LOADING/UNLOADING A PATIENT FOR SCANNING OR LOADING A PHANTOM FOR QA CHECKS. ¿EXECUTION OF QA CHECKS PER USER INSTRUCTIONS ENABLES DETECTION OF TABLE POSITION ERRORS WHEN LOADING OR UNLOADING PHANTOM. ¿SERVICE PERSONNEL ARE INSTRUCTED TO PERFORM AUTO IQ TESTS (ACCEPTANCE/CONSTANCY AND/OR QUICK IQ TESTS) AFTER INSTALLATION, PREVENTIVE MAINTENANCE (PM), AND CORRECTIVE ACTIONS. ¿EXECUTION OF AUTO IQ TESTS, PER SERVICE INSTRUCTIONS, ENABLES DETECTION OF TABLE POSITION ERRORS. ¿FOR ONCOLOGY USAGE, POSITIONAL ACCURACY TESTING USING THE THERAPY TOP CALIBRATION PHANTOM ENABLES DETECTION OF TABLE POSITION ERRORS. ¿DURING A HELICAL SCAN, PER DESIGN, CIRS SHALL VERIFY THE COUCH IS MOVING IN THE DIRECTION SPECIFIED BY THE HOST AND SHALL STOP THE ACQUISITION IF THE COUCH POSITIONS ARE NOT UPDATED AS EXPECTED. ¿OPERATORS/USERS OF THE SYSTEM ARE SPECIFICALLY TRAINED TO POSITION A PATIENT IN SUCH A WAY THAT THERE IS ENOUGH PLAY IN ALL INDWELLING LINES AND CATHETERS TO ALLOW FOR THE TABLE MOTION THAT IS EXPECTED DURING THE SCAN. ¿THERE HAS BEEN NO REPORT OF INJURY TO A PATIENT, OPERATOR OR BYSTANDER AS A RESULT OF THE SERVICE LATCH BECOMING DISENGAGED. THIS CUSTOMER, (B)(6), HAS BEEN CONFIRMED TO BE ON THE CONSIGNEE LIST FOR FIELD SAFETY NOTIFICATION (FSN (B)(4)) 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 HOW TO SERVICE THE PATIENT SUPPORT. THE SERVICE MANUAL CHANGES ARE INTERNAL PHILIPS DOCUMENTS. THE FSE RE-SECURED THE SERVICE LATCH TO RESOLVE THE ISSUE. THE FSE DETERMINED THAT PLANNED MAINTENANCE WAS SCHEDULED THE DAY BEFORE, AND THE SERVICE LATCH WAS NOT LOCKED BACK AFTER MAINTENANCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT COUCH SLIDES A LOT DUE TO THE SERVICE SWITCH (LATCH) BEING DISENGAGED. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER AS A RESULT OF THIS ISSUE. THE FSE REPORTED THAT THE TABLE WAS MOVING ABOUT 10CM. THE FSE REPORTED THAT PLANNED MAINTENANCE WAS PERFORMED THE DAY BEFORE AND THAT HE DID NOT LOCK THE SERVICE LATCH. THE FSE RESECURED THE SERVICE LATCH TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444033 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728306

    Patients

    Seq Age Sex Outcome Treatment
    1