BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 597670 · Received April 28, 2005

    Report

    Report Number
    597670
    Event Type
    Malfunction
    Date Received
    April 28, 2005
    Date of Event
    April 25, 2005
    Report Date
    April 28, 2005
    Manufacturer
    ARMSTRONG MEDICAL INDUSTRIES, INC.
    Product Code
    BZN
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (THIS PRODUCT HAS BEEN SPECIFICALLY DESIGNED TO ELIMINATE THE CLINICAL CONTRAINDICATIONS OF USING SODIUM, POTASSIUM AND BARIUM HYDROXIDE BASED ABSORBENTS WITH COMMON INHALATIONAL ANESTHETIC AGENTS.) THE ANESTHESIA CARTS AND MACHINES WERE IN WORKING ORDER, IT WAS AMSORB THAT WAS DEFECTIVE OR NOT WORKING PROPERLY. THE PRODUCT HAS BECOME HARD AND CLUMPY AND WOULD RESTRICT THE AIR FLOW TO THE PT'S. THIS HAS HAPPENED ON NUMEROUS MACHINES AND IN DIFFERENT ROOMS IN THE OPERATING ROOM. THE INCIDENCES OCCURRED ON: 2005 IN ROOM 2, NEXT DAY IN ROOMS 3 AND 5, FOLLOWING DAY IN ROOM 2, 17 AND 18, 4TH DAYS IN ROOM 24, EXCEPT IN ROOM 2, ALL THE MACHINE WERE SEPARATE INCIDENTS AND MACHINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * BZN ARMSTRONG MEDICAL INDUSTRIES, INC. AMAB3400 080304F21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN