BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 5002374 · Received August 13, 2015

    Report

    Report Number
    3005168196-2015-00784
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    July 16, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012773
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. DEVICE REGAINED FUNCTION, NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110. DURING PREPARATION FOR THE PROCEDURE, THE PUMP MAX WOULD NOT CREATE A VACUUM AND WAS NOT USED. THE PUMP MAX HAS SINCE REGAINED FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534673 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX JCX PENUMBRA, INC. F15128-35 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1