BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX

    MDR report key: 3963286 · Received June 18, 2014

    Report

    Report Number
    2248146-2014-00207
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INADVERTENTLY DISCARDED BY THE MANUFACTURER IN EUROPE AFTER SHIPMENT FROM THE UNITED STATES. AS A RESULT, DEVICE EVALUATION IS NOT POSSIBLE, THEREFORE THE COMPLAINT CANNOT BE CONFIRMED. INTERNAL COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET RETURNED FOR EVALUATION. WHEN THE DEVICE IS RETURNED, AN INVESTIGATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT SUBMITTED WITH THE RESULTS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE IN USE, THE ARTERIAL PRESSURE TRANSDUCER WAS FULLY DISTENDED AND THE USER WAS UNSURE IF THE READING WAS CORRECT. THE TRANSDUCER CAME OFF THE INTEGRATED FILTER VIA THE DIO-CON CONNECTOR ON QUADROX OXYGENATOR. THE USER SWITCHED THE TRANSDUCER WITH ONE ON THE CARDIOPLEGIA TO GAIN READING. PROBLEM CONTINUED IN NEW PLACEMENT. NO PATIENT CONSEQUENCES WERE REPORTED AND THE CASE WAS COMPLETED WITH THE TRANSDUCER ON THE CARDIOPLEGIA SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356690 QUADROX CARDIOPULMONARY DEVICE DWE DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1