BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTON DEAN FLUID WARMER

    MDR report key: 51554 · Received November 18, 1996

    Report

    Report Number
    1720804-1996-00002
    Event Type
    Malfunction
    Date Received
    November 18, 1996
    Date of Event
    October 30, 1996
    Report Date
    November 11, 1996
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    LGZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    FLUID WARMER, FW-537, SHUT ITSELF OFF AT THE START OF A SURGICAL PROCEDURE. THIS REQUIRED ATTENDING PHYSICIANS TO HAVE TO CHANGE OUT THE WARMER'S CASSETTE & RESET UP ALL ANESTHESIA EQUIPMENT, CAUSING A DELAY IN THE START OF THE PROCEDURE, WITH THE PT ALREADY UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTON DEAN FLUID WARMER FLUID WARMER LGZ ALTON DEAN MEDICAL, INC. FW-537 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other