BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AERONEB PROFESSIONAL SYSTEM

    MDR report key: 9643443 · Received January 29, 2020

    Report

    Report Number
    9643443
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    December 28, 2019
    Report Date
    January 10, 2020
    Manufacturer
    AEROGEN LTD.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ARRIVED IN PATIENT ROOM FOR TREATMENT, DISCOVERED APPROXIMATELY 2ML OF FLUID IN AEROGEN MEDICATION CUP (AEROGEN # LPCH 64202). FLUID WITHDRAWN FROM MEDICATION CUP. TESTED AEROGEN WITH NORMAL SALINE, AEROGEN'S LIGHTS SHUT OFF AND STOPPED MISTING WITHIN 10 SECONDS OF BEING TURNED ON. ALL CABLES, WIRES, LOOKED FINE. AEROGEN RED FLAGGED AND REMOVED FROM SERVICE. NEW AEROGEN INSTALLED IN PATIENT'S ROOM, MEDICATION TREATMENT DELIVERED WITHOUT FURTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106862 AERONEB PROFESSIONAL SYSTEM NEBULIZER (DIRECT PATIENT INTERFACE) CAF AEROGEN LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 330 DA