BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENUITY CORE128

    MDR report key: 5091715 · Received September 21, 2015

    Report

    Report Number
    1525965-2015-00254
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    August 25, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 25-AUG-2015, THE CUSTOMER REPORTED THAT DURING THE FIRST POWER CYCLE OF THE DAY, WHILE SETTING UP THE PROTOCOL, THE HEADREST GRAZED THE SURFACE OF THE GANTRY WHEN THE PATIENT SUPPORT WAS LOWERED. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE DEVICE WAS NOT IN CLINICAL USE WHEN THE EVENT OCCURRED AND THAT THERE WAS NO HARM TO THE PATIENT, OPERATOR OR BYSTANDER ASSOCIATED WITH THIS EVENT. THE OPERATOR CONTACTED PHILIPS HELP DESK TO INFORM THEM ABOUT THE ISSUE AND THE FSE WAS DISPATCHED TO THE SITE. THE FSE ARRIVED ON SITE AND EVALUATED THE SYSTEM. THE FSE DID NOT FIND ANY ERRORS IN THE LOG FILES AND STATED THAT THE SYSTEM NEEDED CALIBRATION AND PERFORMED HORIZONTAL ENCODER CALIBRATION TO RESOLVE THE ISSUE. AFTER THE SERVICE, THERE HAVE BEEN TO FURTHER RECURRENCES OF THIS ISSUE AT THE SITE TO DATE. THERE WAS NO PART REPLACEMENT AND NO LOG FILES WERE PROVIDED FOR ENGINEERING ANALYSIS. CT ENGINEERING REVIEWED THIS ISSUE AND DETERMINED THAT THIS EVENT IS ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS HOLD IN PLACE: DESIGN MITIGATIONS FOR PREVENTION OF THE HAZARDOUS SITUATIONS: - STOPPING HORIZONTAL MOTION IN THE PRESENCE OF RESISTANCE FORCE (NOT APPLICABLE FOR VERTICAL, NOT APPLICABLE TO CT INFANT CRADLE), DESIGN MITIGATIONS ENABLING HUMAN RESPONSE: -CONTINUOUS ACTIVATION FOR MANUAL MOTION, -EMERGENCY STOP CONTROLS ENABLE TERMINATION OF MOTION IN HAZARDOUS CONDITION -TABLE MOTION CONTROLS LOCATED ON THE GANTRY ON THE GANTRY AND AS FOOT PEDALS CONTRIBUTING TO VISUAL CONTACT WITH THE PATIENT, -RECOMMENDED SITE PLANNING PROVIDES MEANS FOR VISUAL CONTACT WITH THE PATIENT, -SPEED OF MOTORIZED NON-PROGRAMMED MOTION IS LIMITED, -FREE FLOAT OF THE TABLE PERMITS THE USER TO LOAD OR UNLOAD THE PATIENT WHILE MAINTAINING VISUAL CONTACT WITH THE PATIENT. (APPLICABLE FOR HORIZONTAL), -FOR INWARD SCANS NOT PLANNED ON SURVIEW, EXCEEDING THE SURVIEW LIMITS OR REQUIRES SIGNIFICANT COUCH TRAVEL TO START POSITION; THE SYSTEM REQUIRES THE OPERATOR TO ENABLE AUTOMATIC COUCH MOTION IN PREPARATION FOR THE SCAN. -FOR INWARD SCANS NOT PLANNED ON SURVIEW, SCANS THAT EXCEED THE SURVIEW LIMITS OR SCANS THAT REQUIRE SIGNIFICANT COUCH TRAVEL TO START POSITION, A WARNING MESSAGE IS DISPLAYED TO THE USER. RESTRAINING STRAPS HELPS KEEPING THE PATIENT SECURE (ALSO TO THE INFANT CRADLE) GUIDANCE: IFU WARNING TO WATCH THE PATIENT DURING ALL MOVEMENTS. IFU WARNING TO WATCH FOR COLLISION OF THE INFANT CRADLE WITH THE GANTRY COVERS DURING MOTION. THE FSE PERFORMED HORIZONTAL ENCODER CALIBRATION TO RESOLVE THE ISSUE. SINCE NO BUG REPORTS/LOG FILES WERE PROVIDED, A CAUSE COULD NOT BE DETERMINED.

    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FOOTBOARD HITS THE GANTRY WHEN LOWERING THE TABLE. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. THE FSE REPORTED THAT WHILE LOWERING THE TABLE, THE FOOT EXTENSION GRAZED THE GANTRY FRONT COVER WHEN IT REACHED THE LOWER POSITION. THE FSE EVALUATED THE SYSTEM AND DETERMINED THAT THE COUCH REQUIRED CALIBRATION. THE FSE CALIBRATED THE TABLE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623918 INGENUITY CORE128 SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. 728323

    Patients

    Seq Age Sex Outcome Treatment
    1