BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2061441 · Received March 16, 2011

    Report

    Report Number
    1219856-2011-00097
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 7, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152748 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL, INC. KC6054864

    Patients

    Seq Age Sex Outcome Treatment
    1