BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM TUBING PACK

    MDR report key: 4092674 · Received August 19, 2014

    Report

    Report Number
    2248146-2014-00367
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 28, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, A ROOT CAUSE COULD NOT BE IDENTIFIED. IF ADD'L INFO IS REC'D OR THE DEVICE IS RETURNED, A F/U REPORT WILL BE SUBMITTED. IT SHOULD BE NOTED THAT DURING OUR INVESTIGATION WE FOUND THAT THE PART NUMBER ORDERED (BEQ-TOP 2202) DOES NOT COME WITH THE ROTAFLOW. THEREFORE, THE PART WAS BUILT CORRECTLY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THEY REC'D A TUBING PACK WITHOUT A ROTAFLOW IN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496841 CUSTOM TUBING PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BEQ-TOP 2202 16933-02

    Patients

    Seq Age Sex Outcome Treatment
    1