BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUO FLUID CART - REFURBISHED

    MDR report key: 10271712 · Received July 14, 2020

    Report

    Report Number
    0001954182-2020-00029
    Event Type
    Malfunction
    Date Received
    July 14, 2020
    Date of Event
    June 25, 2020
    Report Date
    September 8, 2020
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    K162421
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 INTELLICART SERIAL NUMBER (B)(6) BY ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON (B)(6) 2020 REVEALED THE CART WON¿T POWER ON WITH WALL POWER. TECHNICIAN FOUND FUSE COVER ON POWER INLET MODULE BURNT. PRODUCT REPAIR: REPAIR OF THE DEVICE WAS PERFORMED BY ZIMMER BIOMET CERTIFIED SERVICE REPAIR TECHNICIAN ON (B)(6) 2020 WHICH INCLUDED REPLACEMENT OF THE FOLLOWING: POWER INLET MODULE (PN 70214, LN 0043022) THE DEVICE, SERIAL NUMBER (B)(6), WAS THEN TESTED AND FUNCTIONED PROPERLY. REVIEW OF THE DEVICE HISTORY RECORD(S) 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 AN INVESTIGATION OF THIS DEVICE IS COMPLETED, A FOLLOW-UP/FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CART TURNED ITSELF OFF AND WOULD NOT TURN ON AGAIN PRIOR TO SURGERY. IT WAS FOUND THAT THE FUSE COVER ON THE POWER INLET MODULE WAS BURNT, HOWEVER THERE WAS NO INDICATION OF SPARKS/SMOKE/FLAMES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737151 DUO FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A 0041870

    Patients

    Seq Age Sex Outcome Treatment
    1