BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP

    MDR report key: 1830702 · Received March 15, 2010

    Report

    Report Number
    3005168196-2010-00182
    Event Type
    Malfunction
    Date Received
    March 15, 2010
    Date of Event
    July 19, 2008
    Report Date
    July 21, 2008
    Manufacturer
    PENUMBRA, INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL EVALUATION: THE PUMP DID NOT OPERATE WHEN TURNED ON. THE FUSE WAS BLOWN OFF, REPLACED THE FUSE WITH A NEW ONE AND IT WAS BLOWN AGAIN. CONCLUSION: ATTEMPTS WERE MADE TO CYCLE THE PUMP ON/OFF. IT WAS CONFIRMED THAT REPETITIVE ON/OFF CYCLING WILL CAUSE THE FUSE TO OVERHEAT AND BLOW. THIS MDR IS BEING FILED AS PART OF THE REMEDIATION ACTION TAKEN AS PER PENUMBRA FEBRUARY 2010 UPDATE TO THE FDA WARNING LETTER DATED DECEMBER 31, 2009.

    Description of Event or Problem · 1

    THE ASPIRATION PUMP WOULD NOT TURN ON. THE POWER OUTLETS WERE CHANGED AS WELL AS THE POWERCORD, BUT THIS DID NOT CHANGE THE OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1