BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR

    MDR report key: 6765060 · Received August 3, 2017

    Report

    Report Number
    0001954182-2017-00010
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    January 19, 2017
    Report Date
    August 3, 2017
    Manufacturer
    DORNOCH
    Product Code
    JCX
    PMA / PMN Number
    PSEE H10
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS BEING REPORTED BY ZIMMER BIOMET AS (B)(4). (B(4), PMA#. K081047; K123188; K133786. THE REPORTED EVENT WAS CONFIRMED BY THE SERVICE TECHNICIAN WHO PERFORMED THE REPAIR AS PER CL-INSTALL CARTS. MD BIOMEDICS WAS CONTACTED ABOUT CART AND DISPATCHED A SERVICE TECHNICIAN TO BE AT THE SITE. THE SERVICE TECHNICIAN ARRIVED AT THE SITE AND INSPECTED THE DEVICE. HE FOUND THAT THE VALVE PACK CONTROL BOARD HAD OVERHEATED. HE REPLACED THE VALVE PACK, BUT THEN FOUND THAT THE DEVICE WAS LEAKING DUE TO A CRACKED BOTTOM PLATE. AN EXCHANGE WAS THEN SCHEDULED FOR THE DEVICE. A NEW CART WAS SHIPPED FROM RIVERSIDE TO THE FACILITY. THE NEW CART WAS CONFIRMED TO HAVE BEEN DELIVERED TO THE HOSPITAL AND THE SERVICE TECHNICIAN WAS DISPATCHED TO THE SITE TO PERFORM THE EXCHANGE. THE TECHNICIAN ARRIVED AT THE SITE AND INSTALLED THE NEW CART. HE THEN VERIFIED THAT THE CART WAS FUNCTIONING AS INTENDED AND PLACED THE CART INTO SERVICE WITHOUT FURTHER INCIDENT. THE DEVICE WAS TESTED AND INSPECTED. THE TECHNICIAN THEN REPACKAGED THE CART SO THAT IT COULD BE RETURNED TO RIVERSIDE. THE EXCHANGED CART WAS PICKED UP FROM THE FACILITY LATER THAT DAY AND WAS CONFIRMED TO HAVE BEEN RETURNED TO RIVERSIDE. THE ROOT CAUSE OF THE CART PRODUCING A BURNING SMELL COULD NOT BE SPECIFICALLY DETERMINED WITH THE PROVIDED INFORMATION. THE ISSUE WAS RESOLVED WITH AN EXCHANGE. THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BURNING SMELL AND DID NOT POWER UP. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546092 ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX DORNOCH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1