BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICT

    MDR report key: 4922150 · Received July 17, 2015

    Report

    Report Number
    1525965-2015-00200
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Report Date
    June 23, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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)(4) 2015, THE CUSTOMER REPORTED THAT AFTER COMPLETING A PATIENT SCAN, WHILE ATTEMPTING TO UNLOAD A PATIENT, THE PATIENT SUPPORT WOULD NOT MOVE OUT COMPLETELY AND WHILE TRYING TO MOVE THE PATIENT SUPPORT OUT, THE HEADREST COLLIDED WITH THE GANTRY. A PHILIPS FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE OPERATORS WERE ABLE TO REMOVE THE PATIENT FROM THE SYSTEM IN A CONTROLLED MANNER, 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. THE REMOTE SUPPORT ENGINEER (RSE) ASKED THE CUSTOMERS TO CHECK IF THERE WAS ANYTHING BLOCKING THE MOVEMENT OF THE COUCH, BUT THE CUSTOMERS DID NOT FIND ANYTHING. THE RSE LOGGED IN REMOTELY TO REVIEW THE LOG FILES AND FOUND HMC_VELOCITY_ENCODER_FAILURE ERROR. THE RSE THEN DISPATCHED A PHILIPS FSE FOR SERVICE TO THE SITE. THE FSE ARRIVED ON SITE AND EVALUATED THE SYSTEM. THE FSE STATED THAT THE MOVEMENT OF THE COUCH WAS MILLIMETER (MM) BY MM, THEREFORE, THE E-STOP DID NOT OPEN TO HALT THE MOTION. THE FSE REVIEWED THE LOG FILES AND CONFIRMED THE ERROR THAT WAS NOTED BY THE RSE. THE FSE DETERMINED THAT THE PATIENT SUPPORT WAS NOT PROPERLY CALIBRATED, AND PERFORMED CALIBRATION OF THE PATIENT SUPPORT TO RESOLVE THE ISSUE. THE FSE COULD NOT PROVIDE INFORMATION ABOUT HOW THE PATIENT SUPPORT WAS OUT OF CALIBRATION. THERE WERE NO PARTS REPLACEMENT. AFTER THIS SERVICE, THERE WERE NO FURTHER RECURRENCES OF THIS ISSUE AT THE SITE. ENGINEERING REVIEWED THIS ISSUE AND DETERMINED THAT THIS EVENT IS ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS APPLY: 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 CALIBRATION OF THE PATIENT SUPPORT TO RESOLVE THE ISSUE. SINCE LOG FILES WERE RETAINED FOR CT ENGINEERING TO EVALUATE, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO THE PHILIPS FIELD SERVICE ENGINEER (FSE) WHILE THEY WERE UNLOADING A PATIENT FOLLOWING A CT CLINICAL PROCEDURE, THE HEADREST HIT THE GANTRY. THE FSE CONFIRMED THERE WAS NO HARM TO A PATIENT, OPERATOR OR BYSTANDER. A PHILIPS REMOTE APPLICATION SPECIALIST (RAS) FOUND AN ERROR HMC_VELOCITY_ENCODER_FAILURE WHEN REVIEWING THE LOGS. THE FSE CALIBRATED THE COUCH TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466118 ICT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1