BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP

    MDR report key: 2021344 · Received February 8, 2011

    Report

    Report Number
    3005168196-2011-00023
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 11, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE PUMP WAS EXTERNALLY LABELED AS NON-FUNCTIONAL BY THE HOSPITAL. THERE WAS NOTHING UNUSUAL ABOUT THE APPEARANCE OF THE PUMP. EVAL, RESULTS: THE PUMP WAS PLUGGED IN AND TURNED ON. THE PRESSURE ADJUSTMENT VALVE WAS RETURNED TO PENUMBRA ADJUSTED SIGNIFICANTLY BELOW MAXIMUM VACUUM. THE VACUUM IN ITS RETURNED STATED WAS -5 IN HG. THE PRESSURE KNOB WAS TWO TURNS COUNTERCLOCKWISE FROM THE MAXIMUM VACUUM ADJUSTMENT. ONCE THE PRESSURE VALVE WAS ADJUSTED, THE VACUUM MEASURED -27.5 IN HG. THE PUMP IS FULLY FUNCTIONAL. THE PUMP VACUUM AS DESCRIBED IN THE COMPLAINT WAS INITIALLY CONFIRMED. HOWEVER, ONCE THE PUMP PRESSURE KNOB WAS CORRECTLY ADJUSTED IT WORKED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    DURING A STROKE CASE THE PENUMBRA SYSTEM ASPIRATION PUMP DID NOT HAVE ANY SUCTION. A SECOND PUMP WAS USED TO COMPLETE THE CASE.

    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