BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA ASPIRATION PUMP CANISTER

    MDR report key: 1934227 · Received December 8, 2010

    Report

    Report Number
    3005168196-2010-00695
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 13, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    JCX
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THESE DEVICES ARE AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATIONS.

    Description of Event or Problem · 1

    THE TECH ATTEMPTED TO ATTACH A LID ON A CANISTER AND THE LID "SHATTERED". THIS HAPPENED WITH FOUR ADDITIONAL CANISTERS. THE HOSPITAL HAD A CANISTER THAT WAS ALREADY ASSEMBLED AND CONNECTED IT TO THE PUMP. WHEN THE PUMP WAS TURNED ON THE CANISTER LID CRACKED AND BROKE. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2010-00696, 3005168196-2010-000697, 3005168196-2010-00698, AND 3005168196-2010-00699.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA ASPIRATION PUMP CANISTER POWERED SUCTION PUMP JCX PENUMBRA INC. B000004

    Patients

    Seq Age Sex Outcome Treatment
    1