BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP

    MDR report key: 2060806 · Received March 11, 2011

    Report

    Report Number
    3005168196-2011-00108
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A F/U MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE FILTER SCREW ON THE PENUMBRA SYSTEM ASPIRATION PUMP BECAME LOOSE WHILE ATTEMPTING TO REMOVE THE FILTER. THE FILTER AND MEDAL SCREW MOVE AS A SINGLE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1