BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 8347568 · Received February 18, 2019

    Report

    Report Number
    0001954182-2019-00016
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 13, 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 · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI/SERIAL NUMBER: (B)(4). THE PREVIOUS REPAIR RECORD FOR INTELLICART SYSTEM SERIAL NUMBER 1160341 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 6 FEB 2019, IT WAS REPORTED FROM (B)(6) HOSPITAL THAT THE UNIT HAD A POWER INLET MODULE THAT WAS HEATING UP AND APPEARED TO BE STARTING TO DEFORM. ON 6 FEB 2019, A ZIMMER BIOMET AUTHORIZED SERVICE TECHNICIAN WAS CONTACTED ABOUT THE CART AND DISPATCHED TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND FOUND THAT THE OUTSIDE OF THE POWER INLET MODULE WAS DEGRADING. HE ALSO NOTICED THAT THE WIRE RUNNING TO THE POWER INLET MODULE APPEARED TO HAVE DEGRADED. ON 8 FEB 2018, THE TECHNICIAN REPLACED THE POWER INLET MODULE (PART # 90204), AND THE WIRING (PART # 30166). THE TECHNICIAN THEN RETURNED THE UNIT TO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED, INSPECTED, AND REPAIRED AS PER CL. SERVICE WORK ORDER DMS-49703-H2W9X7 ON 6 FEB 2019. THE ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO A BAD POWER INLET MODULE AND WIRING RUNNING FROM THE MODULE TO THE MAIN CONTROL BOARD. THE POWER INLET MODULE AND WIRING WILL SUPPLY POWER TO THE UNIT WHEN IT IS CONNECTED TO POWER SOCKET, IF IT IS NOT FUNCTIONING AS INTENDED IT WOULD NOT TURN ON THE UNIT. 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 WIRING 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 WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DUO FLUID CART HAD A POWER INLET MODULE THAT WAS HEATING UP AND APPEARED TO BE STARTING TO DEFORM. THE EVENT TOOK PLACE DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140805 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0024180

    Patients

    Seq Age Sex Outcome Treatment
    1