BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART

    MDR report key: 10140325 · Received June 10, 2020

    Report

    Report Number
    0001954182-2020-00024
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    June 5, 2020
    Report Date
    August 13, 2020
    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 · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). UDI: (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY ADDITIONAL INFORMATION. CURRENT REPAIR PRODUCT EVALUATION PRODUCT REVIEW OF THE DUO CART SERIAL NUMBER (B)(6) BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN (B)(6) 2020 REVEALED THAT THE POWER CORD WAS DAMAGED AND POWER INLET MODULE DAMAGED. PRODUCT REPAIR: REPAIR OF THE DEVICE WAS PERFORMED BY A ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON (B)(6) 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: POWER INLET MODULE (PN90204, LN N/A), FUSE (PN90562, LN N/A) THE DEVICE, SERIAL NUMBER (B)(6), WAS THEN TESTED AND FUNCTIONED PROPERLY. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT IS CONFIRMED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE CART HAD A BURNT POWER CORD. BASED ON ACCOUNT¿S FEEDBACK, THE POWER CORD WAS RUN OVER WHICH CAUSED IT TO BE BURNT AND THE POWER INLET TO BE DAMAGED. TECH REPLACED BOTH POWER CORD AND POWER INLET MODULE. NO FLAME, SPARK, FIRE, OR EXPOSED WIRE. THE EVENT TIMING WAS DURING CLEANING. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602256 DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0026018

    Patients

    Seq Age Sex Outcome Treatment
    1