BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 9075196 · Received September 17, 2019

    Report

    Report Number
    0001954182-2019-00057
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    September 13, 2019
    Report Date
    October 17, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(6). UDI: (B)(4). ON 13 SEPTEMBER 2019, IT WAS REPORTED FROM CANADA - HAMILTON GENERAL HOSPITAL THAT AN INTELLICART UNIT HAD A BURNING SMELL AND WOULD NOT POWER ON. THE DEVICE HISTORY RECORD (DHR) FOR INTELLICART SYSTEM SERIAL NUMBER 1180352 WAS REVIEWED NOTED NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATION (RFD), CHANGE NOTICES (CN), OR ANY OTHER ISSUES WITH MANUFACTURING. THE DHR REVIEW FOUND NO ISSUES WITH THE DEVICE AND ALL VERIFICATIONS, INSPECTIONS, AND TESTS WERE SUCCESSFULLY COMPLETED. ON 13 SEPTEMBER 2019, IT WAS REPORTED FROM CANADA - HAMILTON GENERAL HOSPITAL THAT AN INTELLICART UNIT HAD A BURNING SMELL AND WOULD NOT POWER ON. ON 13 SEPTEMBER 2019, CUSTOMER SERVICE ¿ CANADA WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND COULD NOT CONFIRM THE ODOR BUT WAS ABLE TO CONFIRM THE CART NOT POWERING ON. HE REPLACED THE POWER INLET MODULE FUSES BUT NOTED THEY FAILED AGAIN, DENYING THE CART POWER STILL; THE MODULE ITSELF HAD FAILED. HE ALSO REPLACED THE POWER IV POLE CLAMP (PART #70195) ON THIS UNIT. HE RETURNED ON A LATER DATE AND REPLACED THE POWER INLET MODULE (PART #90204) AND ITS FUSES (PART #90562) AND NOTED THE UNIT POWERED ON CORRECTLY. HE THEN FOUND THE CYLINDER 2 TINT HAD GONE BAD, SO HE INSTALLED NEW CYLINDER TINT (PART #70073 AND LOT CODE #0041414 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 13 SEPTEMBER 2019. BECAUSE THE REPORTED EVENT OF A BURNING SMELL WAS UNABLE TO BE CONFIRMED DURING INSPECTION OF THE DEVICE, IT IS NOT KNOWN WITH THE INFORMATION AVAILABLE WHAT CAUSE THE REPORTED BURNING SMELL. THEREFORE, BASED ON THE INFORMATION PROVIDED, A SPECIFIC ROOT CAUSE OF THE BURNING SMELL CANNOT BE DETERMINED. IN ADDITION, THE ROOT CAUSE OF THE UNIT NOT POWERING ON WAS DUE TO A MALFUNCTIONING POWER INLET MODULE. THE POWER INLET MODULE IS THE LOCATION OF THE AC POWER INLET, POWER SWITCH, AND FUSES FOR THE CART. THE POWER INLET MODULE FAILING WOULD DENY THE CART POWER. 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, ITS FUSES, THE POWER IV POLE CLAMP, AND THE CYLINDER TINT 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 · 0

    NO ADDITIONAL EVENT INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS UNIT IS NOT POWERING ON AND THERE IS A BURNING SMELL. EVENING TIMING WAS AFTER THE SURGERY DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872340 DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0027736

    Patients

    Seq Age Sex Outcome Treatment
    1