BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRILLIANCE 64

    MDR report key: 4294079 · Received November 25, 2014

    Report

    Report Number
    1525965-2014-00190
    Event Type
    Injury
    Date Received
    November 25, 2014
    Report Date
    October 29, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL MDR MAILED ON NOVEMBER 25, 2014. ON (B)(6) 2014, THE CUSTOMER REPORTED THAT WHILE LOADING A PATIENT ONTO THEIR BRILLIANCE 64 SLICE CT SYSTEM, THE PATIENT HIT THEIR LEFT LEG ON THE INTERVENTIONAL RAIL WHICH RESULTED IN A LACERATION OF THE PATIENT'S LEFT LEG. THE CUSTOMER REPORTED THAT THE PATIENT WAS TAKING BLOOD THINNERS AT THE TIME AND THAT THE WOUND BLED A LOT. THE TECHNOLOGIST BANDAGED THE LACERATION WITH GAUZE AND APPLIED PRESSURE AND COMPLETED THE PROCEDURE SUCCESSFULLY. AFTER THE PROCEDURE, A PHYSICIAN AT THE SITE EVALUATED THE PATIENT. THE PHYSICIAN CLEANED THE LACERATION, APPLIED STERI-STRIPS, AND RELEASED THE PATIENT. THE PHYSICIAN¿S EVALUATION OF THE PATIENT DETERMINED THAT STITCHES WERE NOT NECESSARY. ON (B)(6) 2014, THE CUSTOMER CONTACTED THE PATIENT'S SON TO FOLLOW UP ON THE PATIENT'S CONDITION. THE CUSTOMER WAS NOTIFIED THAT THE PATIENT WAS TAKEN TO AN AFTER-HOURS CLINIC THE NIGHT BEFORE, AND THAT THE PATIENT'S WOUND HAD BEEN STITCHED. ON THE SAME DAY, THE CUSTOMER CONTACTED THE PHILIPS HELP DESK TO INFORM THEM OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE ARRIVED ON SITE AND EVALUATED THE SYSTEM. THE FSE CONFIRMED THAT THE PATIENT WAS ELDERLY ((B)(6) YEARS, MALE, WEIGHT (B)(6)), WITH PAPER THIN SKIN AND WAS ON BLOOD THINNERS. THE FSE SAID THAT THE PATIENT RECEIVED ABOUT 1-2 STITCHES ON THE WOUND. THE FSE REMOVED THE INTERVENTIONAL RAILS AND SENT THEM TO THE BIU FOR FURTHER EVALUATION BY CT ENGINEERING. THERE HAVE BEEN NO FURTHER RECURRENCES AT THE SITE AFTER THE SERVICE. CT ENGINEERING INVESTIGATED THE ISSUE AND THE RETURNED RAIL TO DETERMINE ROOT CAUSE. ENGINEERING TESTED THE RAIL FOR SHARPNESS USING A CALIBRATED SHARP EDGE TESTER, AS PER UL 1439-2013. AFTER TESTING, ENGINEERING DETERMINED THAT THE RAILS DID NOT CUT THROUGH THE SENSING TAPE PER THE TESTS RECOMMENDED IN UL1439-2013; HENCE, THESE PARTS WOULD BE CONSIDERED ACCEPTABLE. THE DETAILS OF THE TESTS IS DOCUMENTED. CT ENGINEERING DETERMINED THIS ISSUE TO BE AN ACCEPTABLE RISK. THE FOLLOWING MITIGATIONS ARE APPLICABLE IN THIS CASE: ¿ THE RAILS PASS THE SHARPNESS TEST AS PER UL 1439-2013. ¿ ALL GANTRY, COUCH AND CONSOLE EDGES AND CORNERS OF PARTS THAT CAN BE REACHED SHALL COMPLY WITH IEC 60601-1. THE FSE REMOVED THE INTERVENTIONAL RAIL TO RESOLVE THE ISSUE. CT ENGINEERING COULD NOT REPRODUCE THE EVENT WITH THE RETURNED INTERVENTIONAL RAIL FROM THE SITE. THUS, AS PER THE STATEMENTS AND TROUBLESHOOTING ACTIVITIES OF THE FSE, A PROBABLE ROOT CAUSE WAS DETERMINED THAT THE EVENT OCCURRED BECAUSE THE PATIENT WAS ELDERLY, WITH THIN SKIN, AND WAS ON BLOOD THINNERS, WHICH LED TO EXCESSIVE BLEEDING.

    Additional Manufacturer Narrative · 1

    (B)(4). WE WILL FILE A FOLLOW UP MDR AT THE COMPLETION OF THE INVESTIGATION. INITIAL MDR MAILED ON NOVEMBER 25, 2014.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2014, WHILE LOADING A PATIENT ONTO THEIR BRILLIANCE 64 SLICE CT SYSTEM, THE PATIENT HIT THEIR LEFT LOWER LEG ON THE INTERVENTIONAL RAIL, RESULTING IN LACERATION OF THE PATIENT'S LOWER LEG. THE CUSTOMER REPORTED THAT THE PATIENT WAS TAKING BLOOD THINNERS AT THE TIME AND THAT THE WOUND "BLED A LOT". THE TECHNOLOGIST BANDAGED THE LACERATION WITH GAUZE AND APPLIED PRESSURE BEFORE COMPLETING THE PATIENT'S PROCEDURE. AFTER THE PROCEDURE, A PHYSICIAN AT THE SITE EVALUATED THE PATIENT. THE PHYSICIAN CLEANED THE LACERATION, APPLIED STRI-STRIPS, AND RELEASED THE PATIENT. THE PHYSICIAN'S EVALUATION OF THE PATIENT DETERMINED THE STITCHED WERE NOT NECESSARY. THE CUSTOMER CONTACTED THE PATIENT'S SON ON (B)(6) 2014 TO FOLLOW UP ON THE PATIENT'S CONDITION. THE CUSTOMER WAS NOTIFIED THAT THE PATIENT WAS TAKEN TO AN AFTERHOURS CLINIC THE NIGHT BEFORE, AND THAT THE PATIENT'S WOUND HAD BEEN STITCHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766451 BRILLIANCE 64 JAK PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 728231

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR