BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT CPB PACK

    MDR report key: 3994350 · Received July 23, 2014

    Report

    Report Number
    2248146-2014-00225
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWF
    PMA / PMN Number
    K090533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND AN INVESTIGATION IS BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE RESULTS WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A KIT WAS REC'D WHERE THE "STERILE INTEGRITY IS IN QUESTION". NO PATIENT WAS INVOLVED IN THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430982 ADULT CPB PACK CARDIOPULMONARY DEVICE DWF DATASCOPE CORP. BO-TOP-19100

    Patients

    Seq Age Sex Outcome Treatment
    1