BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP 110

    MDR report key: 2761025 · Received September 26, 2012

    Report

    Report Number
    3005168196-2012-00330
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISTRIBUTOR'S INVESTIGATION RESULTS: THE PUMP ROTOR IS LOCKED AND WILL NOT ROTATE DUE TO A MISALIGNED HOUSING WHICH CAUSES OVER-CURRENT AND THE PUMP FUSE TO BLOW. THE HOUSING POSITION WAS CHANGED SO THAT THE ROTOR COULD ROTATE. IT IS UNKNOWN WHY THE ROTOR HOUSING WAS MISALIGNED. DEVICE EVALUATED BY DISTRIBUTOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PUMP WOULD NOT TURN ON DURING A STUDY SESSION AT THE HOSPITAL. AT A TRAINING SESSION THE DAY BEFORE, THERE WAS NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM ASPIRATION PUMP 110 BTA & JCX BTA PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1