BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTHREX (CONTINUOUS WAVE II) ARTHROSCOPY PUMP

    MDR report key: 310849 · Received January 3, 2001

    Report

    Report Number
    310849
    Event Type
    Death
    Date Received
    January 3, 2001
    Date of Event
    December 19, 2000
    Report Date
    January 3, 2001
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRX
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SHOULDER ARTHROSCOPY. ARTHROSCOPY PUMP USED FOR IRRIGATION INTO SHOULDER. DURING PROCEDURE, ETCO2 DECREASED, BRADYCARDIA THEN CARDIAC ARREST. PT RESUSCITATED. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78 ARTHREX (CONTINUOUS WAVE II) ARTHROSCOPY PUMP ARTHROSCOPY PUMP HRX ARTHREX, INC. AR-6400 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death