BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPS CONSOLE

    MDR report key: 6458148 · Received April 4, 2017

    Report

    Report Number
    1649914-2017-00031
    Event Type
    Malfunction
    Date Received
    April 4, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 8, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DTR
    PMA / PMN Number
    K041979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL CONSOLE IS FOR EXPORT ONLY; HOWEVER, THIS REPORT IS BEING FILED BECAUSE THE MODEL IS SIMILAR TO THE DOMESTIC MODEL 5201260.

    Description of Event or Problem · 1

    THE INTERNATIONAL DISTRIBUTOR ((B)(6)) REPORTED AN ISSUE ENCOUNTERED WITH THE MPS CONSOLE DURING USE. THE DISTRIBUTOR NOTIFIED THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WHILE HE WAS AT THE FACILITY TO PERFORM ROUTINE SCHEDULED PREVENTIVE MAINTENANCE. THE DISTRIBUTOR STATED THAT THE VENT VALVE OPENED WHEN IT SHOULD NOT HAVE AFTER PRIMING THE SYSTEM. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE FSE VERIFIED THE RELEVANT ERROR CODE IN THE LOG DATA OF THE CONSOLE. THE FSE REPLACED THE FLUID LEVEL SENSOR AND COMPLETED THE PREVENTIVE MAINTENANCE, AND THE CONSOLE WAS RELEASED BACK TO USE FOLLOWING SUCCESSFUL COMPLETION OF VERIFICATION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241192 MPS CONSOLE CPBP HEAT EXCHANGER DTR QUEST MEDICAL, INC. 5202450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention