BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINUOUS WAVE III

    MDR report key: 1374412 · Received April 10, 2009

    Report

    Report Number
    1374412
    Event Type
    Malfunction
    Date Received
    April 10, 2009
    Date of Event
    March 24, 2009
    Report Date
    April 10, 2009
    Manufacturer
    ARTHREX ARTHROSCOPY INSTRUMENTS, INC.
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PUMP SENSOR NOT SENSING THE PRESSURE IN THE PATIENT'S SHOULDER LIKE IT SHOULD HAVE RESULTING IN EXTRAVASATION OF FLUID INTO THE SHOULDER JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS WAVE III PUMP, ARTHROSCOPIC HRX ARTHREX ARTHROSCOPY INSTRUMENTS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR