BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV

    MDR report key: 17166662 · Received June 20, 2023

    Report

    Report Number
    0001954182-2023-00073
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 30, 2023
    Report Date
    October 9, 2023
    Manufacturer
    DORNOCH
    Product Code
    JCX
    UDI-DI
    00889024501638
    PMA / PMN Number
    K190789
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION INTO THE REPORTED EVENT HAS BEEN INITIATED UNDER (B)(4). ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS AND ANY ACTIONS TAKEN BY THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). 0001954182-2023-00073-1. REVIEW OF THE MOST RECENT REPAIR RECORD DETERMINED THE UNIT WAS CONFIRMED TO HAVE A MELTED AND BURNT POWER INLET MODULE, POWER CORD, AND POWER INLET MODULE CABLE. THE POWER INLET MODULE, POWER CORD, AND POWER INLET MODULE CABLE WERE REPLACED AND RESOLVED THE REPORTED ISSUE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OUTSIDE OF SURGERY, IT WAS OBSERVED THAT WHERE THE CORD PLUGS IN, IT WAS MELTED AND BURNT. THE POWER INLET MODULE SHORTED OUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE IS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

    Description of Event or Problem · 0

    THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458005 DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT JCX DORNOCH N/A 44168 00889024501638

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose