BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC STATION

    MDR report key: 8325848 · Received February 11, 2019

    Report

    Report Number
    0001954182-2019-00015
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    January 16, 2019
    Report Date
    March 13, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K133786
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE PREVIOUS REPAIR RECORD FOR ULTRA EVACUATION UNIT SERIAL NUMBER (B)(4) WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD) OR ANY OTHER ISSUES WITH THE REPAIR. THE PREVIOUS REPAIR RECORD REVIEW FOUND NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ON 16 JANUARY 2019, IT WAS REPORTED FROM (B)(6) THAT AN EVAC WAS NOT CONNECTING TO EITHER CART AND IT HAD AN ELECTRICAL BURNING SMELL. BAYSIDE BIOMEDICAL SERVICES INC. WAS CONTACTED ABOUT THE EVAC AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. ON (B)(6) 2019, THE TECHNICIAN CONFIRMED THE REPORTED EVENT AND REPLACED THE UNIT¿S COUPLER (PART #70027 AND LOT CODE #0029382), BUT THE ACCOUNT CALLED HIM BACK DUE TO EVAC COMM ERRORS. HE RETURNED ON (B)(6) 2019 AND TROUBLESHOT THE UNIT. HE RECEIVED MANY ERRORS THAT WERE NOT CONSISTENT. IN TOTAL, HE NOTED INTERMITTENT EVAC COMM ERRORS AS WELL AS BLEACH AND ENZYME OUT ERRORS. TO RESOLVE THE BLEACH AND ENZYME ERRORS, HE WOULD REPLACE THE ENZYME TUBING (PART #91800), THE BLEACH TUBING (PART #91476), THE PICKUP STRAWS (PART #91557) AS WELL AS THE BLEACH CHEMICAL VALVE (PART #70094), THE ENZYME CHEMICAL VALVE (PART #70095), AND THE CHEMICAL FLOW SENSOR (PART #91220). HE ALSO REPLACED THE COUPLER AGAIN (PART #70027 AND LOT CODE #0029382) AS WELL AS THE UNIT¿S MAIN CONTROL BOARD (PART #91930). IT IS BELIEVED THAT THE REPLACEMENT MAIN CONTROL BOARD SOLVED THE COMMUNICATION ERROR ISSUE WHEN THE TECHNICIAN RETURNED. HE THEN VERIFIED THAT THE DEVICE WAS FUNCTIONING AS INTENDED AND RETURNED IT TO SERVICE WITHOUT INCIDENT. THE UNIT WAS TESTED, INSPECTED, AND REPAIRED AS PER CL. SERVICE WORK ORDER (B)(4) ON 16 JANUARY 2019. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE FOR THE UNIT NOT CONNECTING TO CARTS WAS DUE TO A MALFUNCTIONING MAIN CONTROL BOARD. THE MAIN CONTROL BOARD OVERSEES ALL ELECTRICAL FUNCTION OF THE UNIT; A MALFUNCTIONING CONTROL BOARD COULD DENY THE ABILITY TO CONNECT TO CARTS AND MAKE THE UNIT ISSUE COMMUNICATION ERRORS, SUCH AS IN THE REPORTED EVENT. THE MALFUNCTIONING CONTROL BOARD COULD ALSO BE THE SOURCE OF THE BLEACH AND ENZYME COMPONENT ISSUES EXPERIENCED, AS A BAD BOARD COULD ESSENTIALLY LOSE ALL ELECTRICAL FUNCTION IN THE EVAC, WHICH WOULD CAUSE THE CART TO ISSUE NUMEROUS ERRORS WHEN CONNECTED. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE ENZYME AND BLEACH TUBING, ENZYME AND BLEACH CHEMICAL VALVES, CHEMICAL FLOW SENSOR, AND PICKUP STRAWS, AS WELL AS THE COUPLER AND MAIN CONTROL BOARD WERE REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP MDR WILL BE SUBMITTED. EVALUATED ON SITE BY EXTERNAL CONTRACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS NOT CONNECTING TO EITHER CART AND HAD AN ELECTRICAL BURNING SMELL. THE EVENT OCCURRED DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120949 EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0019932

    Patients

    Seq Age Sex Outcome Treatment
    1