BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTPUMP DUAL CHANNEL

    MDR report key: 3063577 · Received April 17, 2013

    Report

    Report Number
    0001811755-2013-00822
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    KCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SMARTPUMP DUAL CHANNEL WAS RETURNED TO STRYKER INSTRUMENTS FOR EVALUATION DUE TO ALLEGEDLY NOT HOLDING PRESSURE DURING A PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164036 SMARTPUMP DUAL CHANNEL TOURNIQUET, PNEUMATIC KCY STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1