BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOPCOCK 9 IN EXTENSION

    MDR report key: 31891 · Received March 22, 1996

    Report

    Report Number
    31891
    Event Type
    Malfunction
    Date Received
    March 22, 1996
    Date of Event
    March 8, 1996
    Report Date
    March 8, 1996
    Manufacturer
    ARGON MEDICAL CORP.
    Product Code
    KRK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY CHANGED CVP PRESSURE SET UP. PRIOR TO CHANGE, WAVEFORM WAS GOOD. AFTER CHANGE, FACILITY NOTED A LEAK AT THE FAST FLUSH CONNECTOR. SET WAS DISCONNECTED, 2ND SET PUT UP AND IT CAUSED THE MONITOR TO BLANK OUT. BIOMED RESEARCHED MONITOR AND CHECKED SYSTEM AND FOUND NO MALFUNCTION WITH SYSTEM. 2ND SET DISCONTINUED AND ENTIRE PRESSURE SET REPLACED. 3RD SET WORKING FINE, GOOD CVP WAVEFORM PRESENT. TUBING SETS 1 & 2 GIVEN TO NURSE MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOPCOCK 9 IN EXTENSION STOPCOCK KRK ARGON MEDICAL CORP. 95125843

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR