BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 7139377 · Received December 21, 2017

    Report

    Report Number
    0001954182-2017-00046
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    December 4, 2017
    Report Date
    March 8, 2018
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE SERIOUS INJURY AND HAS NOT BEEN PREVIOUSLY REPORTED AS A SERIOUS INJURY. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(6). K081047; K123188; K133786. THE PRODUCT WILL BE EVALUATED BY AN EXTERNAL CONTRACTOR. ONCE THE EVALUAION/INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. PRODUCT EVALUATED BY EXTERNAL CONTRACTOR

    Description of Event or Problem · 1

    IT WAS REPORTED THE CART'S FLUID WAS LEAKING FROM THE BOTTOM. THE REPORTED ISSUE WAS NOTICED AFTER SURGERY AND IT WAS CONFIRMED THAT THERE WAS FLUID EXPOSURE IN OR. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917157 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH 0025012

    Patients

    Seq Age Sex Outcome Treatment
    1