BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMETRON SERIES 4000

    MDR report key: 2190989 · Received August 1, 2011

    Report

    Report Number
    2190989
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NITROGEN MANIFOLD NOT WORKING PROPERLY. MANIFOLD DELIVERS GAS VIA RESERVE SIDE, NOT PRIMARY SIDE. MAINLY SEEN ON LEFT BANK SIDE OF MANIFOLD. THIS MANIFOLD ALSO DISPLAYS A VISUAL AND AUDIBLE INDICATOR THAT GAS TANKS ARE EMPTY, HOWEVER THE MANIFOLD HAS NOT PNEUMATICALLY SWITCHED OVER YET. FALSE INDICATION TO USER WHO IDENTIFIES EMPTY CYLINDERS BY VISUAL AND AUDIBLE INDICATOR, AND EXTERNAL GAUGES, WHICH APPEAR TO BE AT 0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMETRON SERIES 4000 REGULATOR, PRESSURE, GAS CYLINDER CAN ALLIED HEALTHCARE PRODUCTS, INC. 4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *