BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPUMP DUAL CHANNEL

    MDR report key: 2024003 · Received February 14, 2011

    Report

    Report Number
    1811755-2011-00448
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 18, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    KCY
    PMA / PMN Number
    K924273
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN REC'D AT THE MFR FOR TESTING. ACCORDING TO THE CONTACT AT THE ACCOUNT, THE DEVICE WILL BE SHIPPED BACK TO THE MFR FOR REPAIR WITHIN THE NEXT DAY. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A F/U REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE DEVICE WOULD NOT HOLD PRESSURE WHICH CAUSED SOME LEAKAGE INTO THE SURGICAL SITE. THE PRESSURE WAS ADJUSTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PT/USER INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPUMP DUAL CHANNEL PNEUMATIC TOURNIQUET KCY STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK