BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM PERFUSION PACK

    MDR report key: 4152461 · Received October 6, 2014

    Report

    Report Number
    2248146-2014-00415
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER IS QUESTIONING THE PACK'S STERILITY. THEY WERE NOT ABLE TO CLARIFY IF THIS PACK HAD BEEN PALLETIZED OR NOTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622292 CUSTOM PERFUSION PACK CARDIOPULMONARY DWE DATASCOPE CORP. 17156-04

    Patients

    Seq Age Sex Outcome Treatment
    1