BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERPULSE HANDPIECE SET W/HIGH FLOW

    MDR report key: 4251045 · Received November 6, 2014

    Report

    Report Number
    4251045
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 23, 2014
    Report Date
    November 6, 2014
    Manufacturer
    STRYKER INSTRUMENTS,DIV OF STRYKER CORP.
    Product Code
    FQH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE INTERPULSE WAS OPENED ONTO THE BACK TABLE. WHEN IT WAS PLUGGED INTO THE FLUID AND HOOKED TO SUCTION IT WOULD NOT TURN ON. THE BATTERY COMPARTMENT WAS OPENED AND CHECKED. IT STILL WOULD NOT FUNCTION. A NEW INTERPULSE WAS OPENED AND USED TO COMPLETE PROCEDURE WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716087 INTERPULSE HANDPIECE SET W/HIGH FLOW LAVAGE, JET, SYSTEM FQH STRYKER INSTRUMENTS,DIV OF STRYKER CORP. * 141040012

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR