BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICTOR

    MDR report key: 170222 · Received May 18, 1998

    Report

    Report Number
    170222
    Event Type
    Death
    Date Received
    May 18, 1998
    Date of Event
    May 5, 1998
    Report Date
    May 18, 1998
    Manufacturer
    VICTOR MEDICAL PRODUCTS DIV.
    Product Code
    CAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FOR OUTPATIENT PROCEDURE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH PAPILLOTOMY. DURING PROCEDURE, OXYGEN SATURATION BEGAN TO FALL, CODE WAS CALLED, WITH INCREASE OF O2 CALLED FOR, IT WAS DISCOVERED THAT THE O2 FLOW METER WAS NOT WORKING. ANOTHER METER WAS OBTAINED & WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICTOR O2 FLOW METER CAX VICTOR MEDICAL PRODUCTS DIV. O2 FLOW METER 0-15 L PER MIN *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death