BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED

    MDR report key: 10194568 · Received June 25, 2020

    Report

    Report Number
    0001954182-2020-00026
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 30, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K133786
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). CURRENT REPAIR. PRODUCT EVALUATION: PRODUCT REVIEW OF THE ULTRA CART SERIAL NUMBER (B)(6) BY ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON 08 JUNE 2020 REVEALED THAT THERE WAS NO PROBLEM FOUND, TECHNICIAN COULD NOT DUPLICATE LEVEL SENSOR ISSUE. PRODUCT REPAIR: REPAIR OF THE DEVICE WAS NOT PERFORMED BECAUSE THERE WAS NO PROBLEM FOUND. DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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

    THERE IS NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). PMA/510K: K081047; K123188; K133786. EVALUATION AND INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL / FINAL MEDWATCH WILL BE FILED. EVALUATED BY EXTERNAL CONTRACTOR.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE UNIT WAS SHOWING FULL WHEN BOTH CYLINDERS WERE EMPTY. THE EVENT TIMING WAS DURING CLEANING. THERE WAS NO HARM TO THE PATIENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660986 ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1