BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP MAX 110

    MDR report key: 5085462 · Received September 17, 2015

    Report

    Report Number
    3005168196-2015-00903
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    JCX
    UDI-DI
    00814548012773
    PMA / PMN Number
    K122756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. DEVICE IS OPERATIONAL AND WON'T RETURN.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX). AFTER THE FIRST PASS DURING THE PROCEDURE THE PUMP MAX FAILED TO TURN BACK ON. THE PROCEDURE SUCCESSFULLY CONTINUED USING ANOTHER PENUMBRA PUMP. THERE WAS NO REPORT OF AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615532 PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX JCX PENUMBRA, INC. 00814548012773

    Patients

    Seq Age Sex Outcome Treatment
    1