BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 9764929 · Received February 27, 2020

    Report

    Report Number
    0001954182-2020-00013
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    February 20, 2020
    Report Date
    April 22, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER: (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: DATE OF REPORT, UDI #, CONCOMITANT MEDICAL PRODUCTS, PMA/510K, IF FOLLOW-UP, WHAT TYPE, DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE, USAGE OF DEVICE. UDI #: (B)(4) PRODUCT REVIEW OF THE DUO FLUID CART W/ SMOKE EVAC (00514010200) SERIAL NUMBER: (B)(4) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON 24 FEBRUARY 2020 REVEALED THAT THE POWER INLET MODULE HAD FAILED. HOWEVER, THERE WERE NO SIGNS OF THE UNIT SMOKING AS ALL WIRES ON THE UNITED LOOKED IN GOOD WORKING ORDER. THE POWER INLET MODULE WAS REPLACED. THE TECHNICIAN ALSO FOUND THE VACUUM PUMP WAS AN OLDER STYLE SO IT WAS PROACTIVELY REPLACED. THE UNIT WAS TESTED AND RETURNED TO SERVICE. REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON 24 FEBRUARY 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: INTELLICART POWER SUPPLY (PART#: 70097 AND LOT CODE#: 0041385). ADDITIONAL REPAIR INCLUDED PROACTIVELY REPLACING THE INTELLICART VACUUM PUMP CAPACITOR (PART#: 70216 AND LOT CODE#: 0042731). THE DEVICE, SERIAL NUMBER: (B)(4), WAS THEN TESTED AND FUNCTIONED PROPERLY. IT WAS REPAIRED, INSPECTED AND TESTED. THE DUO FLUID CART W/ SMOKE EVAC (00514010200) SERIAL NUMBER: (B)(4) HAS BEEN PREVIOUSLY REPAIRED/EVALUATED 2 TIMES AS DOCUMENTED IN THE REPAIR REPORTS IN CRM. THE LAST REPAIR WAS 8 MARCH 2019 BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN WHERE IT WAS REPORTED THAT THE UNIT WAS NOT DRAINING PROPERLY. THE TECHNICIAN REMOVED A PLASTIC FOREIGN OBJECT FROM CYLINDER #1. THE UNIT WAS TESTED AND RETURNED TO SERVICE. THIS IS NOT A RELATED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MALFUNCTIONING POWER INLET MODULE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE EVENT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CART WAS SMOKING FROM THE BACK. THE EVENT TIMING WAS PRIOR TO SURGERY. THERE WAS NO HARM TO THE PATIENT AND NO DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227452 DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0025687

    Patients

    Seq Age Sex Outcome Treatment
    1