BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 8945099 · Received August 29, 2019

    Report

    Report Number
    0001954182-2019-00053
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 29, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI #: (B)(4). ON (B)(6) 2019, IT WAS REPORTED FROM (B)(6) MEDICAL CENTER THAT AN INTELLICART UNIT WOULD NOT POWER ON THE MONITOR. THE PREVIOUS WORK ORDER IN CUSTOMER RELATIONSHIP MANAGEMENT (CRM) FOR INTELLICART SYSTEM 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 WORK ORDER NOTED NO ISSUES WITH THE DEVICE AFTER REPAIR AND ALL VERIFICATIONS, INSPECTIONS AND TESTS WERE SUCCESSFULLY COMPLETED. ON (B)(6) 2019, IT WAS REPORTED FROM (B)(6) MEDICAL CENTER THAT AN INTELLICART UNIT WOULD NOT POWER ON THE MONITOR. ON 14 AUGUST 2019, C3 TECH, LLC WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND CONFIRMED POWER ISSUES, NOTING THAT THE CART WOULD NOT POWER ON WHEN PLUGGED INTO AN OUTLET. HE ALSO NOTED A CLICKING NOISE AND BURNING SMELL/ THE TECHNICIAN REPLACED THE POWER INLET MODULE (PART #90204) AND THE APPROPRIATE FUSES (PART #90562) AND THEN VERIFIED THAT THE UNIT WAS FUNCTIONING AS INTENDED. THE TECHNICIAN THEN RETURNED THE UNIT TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED. SERVICE WORK ORDER (B)(4) ON 14 AUGUST 2019. THE ROOT CAUSE FOR THE UNIT NOT POWERING ON WAS DUE TO A FAILED POWER INLET MODULE. THE POWER INLET MODULE IS WHERE THE AC POWER CABLE PLUGS INTO THE UNIT AND ALSO HOUSES THE FUSES FOR THE CART. THE MODULE FAILING WOULD PREVENT THE CART FROM GETTING POWER, AND THE UNIT WOULD NOT TURN ON AT ALL. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE POWER INLET MODULE AND ITS FUSES WERE REPLACED. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. BASED ON THE INFORMATION PROVIDED, THIS INVESTIGATION DETERMINED THAT THERE IS NO NEED FOR FURTHER ACTION (IE/CAPA/SCAR/HHE/D) AT THIS TIME. THIS COMPLAINT WILL BE TRACKED AND TRENDED PER COMPLAINT TRENDING PROCEDURE FOR ANY ADVERSE TRENDS THAT MAY REQUIRE ADDITIONAL ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WOULD NOT POWER ON THE MONITOR. THE EVENT TIMING WAS BEFORE SURGERY. THE INVESTIGATION REVEALED THE UNIT HAD A BURNING SMELL. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738558 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0024178

    Patients

    Seq Age Sex Outcome Treatment
    1