BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAC STATION

    MDR report key: 9310429 · Received November 12, 2019

    Report

    Report Number
    0001954182-2019-00073
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 12, 2019
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED UNDER ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ON 11 OCTOBER 2019, RIVER CITY ELECTRIC LLC WAS CONTACTED ABOUT THE CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE TECHNICIAN ARRIVED AT THE SITE AND FOUND THAT THE COUPLER WAS NOT FUNCTIONING AND THE BOOT WAS SLID DOWN, EXPOSING INNER WIRES. THE COUPLER HANDLE ITSELF WAS NOT BROKEN. HE NOTED THAT THE COUPLER ITSELF WAS NOT GETTING POWER FROM THE CONTROL BOARD. WHEN HE LIFTED THE EVAC¿S LID HE FOUND AN INSECT LYING DEAD ON THE CONTROL BOARD ACROSS THE FUSES. HE SWAPPED THE FUSES WITH SPARES, BUT THE BOARD HAD INDEED FAILED. HE RETURNED ON 17 OCTOBER 2019 AND REPLACED THE CONTROL BOARD (PART #70065 AND LOT CODE #0041683) 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. THE ROOT CAUSE FOR THE UNIT NOT CONNECTING TO CARTS WAS DUE TO A FAILED CONTROL BOARD. THE CONTROL BOARD OVERSEES THE ELECTRICAL FUNCTIONS OF THE UNIT; THE BOARD FAILING SUCH AS WHAT THE TECHNICIAN OBSERVED WOULD RESULT IN THE COUPLER NOT BEING ABLE TO CONNECT TO CARTS. IN ADDITION, THE REPORTED EVENT OF THE COUPLER HANDLE BEING DAMAGED WAS NOT CONFIRMED AS THE HANDLE WAS CONFIRMED TO NOT BE DAMAGED. THEREFORE, A SPECIFIC ROOT CAUSE OF THE COUPLER HANDLE DAMAGE REPORT CANNOT BE DETERMINED. THE REPORTED EVENT WAS CONFIRMED DURING INSPECTION OF THE DEVICE AND THE DEVICE WAS NOTED TO BE FUNCTIONING AS INTENDED AFTER THE CONTROL BOARD WAS 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 FOR ANY ADVERSE TRENDS THAT MAY REQUIRE ADDITIONAL ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD A DAMAGED COUPLER HANDLE AND WOULD NOT CONNECT TO THE CARTS. THE EVENT TIMING WAS DURING CLEANING AND DID NOT RESULT IN ANY HARM OR INJURY. DURING THE INVESTIGATION, EXPOSED WIRES WERE IDENTIFIED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105987 EVAC STATION APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0026623

    Patients

    Seq Age Sex Outcome Treatment
    1