BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOR PHASE PLUS HUMIDIFIER

    MDR report key: 136126 · Received December 2, 1997

    Report

    Report Number
    2020364-1997-00024
    Event Type
    Other
    Date Received
    December 2, 1997
    Date of Event
    November 4, 1997
    Report Date
    December 2, 1997
    Manufacturer
    SIMS/RESPIRATORY SUPPORT PRODUCTS, INC.
    Product Code
    BTT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT OF A 75 Y/O MALE PT (WEIGHT UNREPORTED), THE VAPOR PHASE PLUS HUMIDIFIER, REPORTEDLY, OVERHEATED. THE TRANSFER CHAMBER MELTED. IT WAS OBSERVED THAT THREE QUADRANTS OF THE TRANSFER CHAMBER MATERIAL "BURNED". THE HUMIDIFIER WAS RAN DRY. REPORTEDLY, THE DEVICE DID NOT SHUT OFF WHEN THE OVERHEATING OCCURRED; HOWEVER, THE INTERNAL FUSE DID BLOW. THE HUMIDIFIER WAS CONNECTED TO A MODEL 7299 PURITAN BENNETT VENTILATOR; AIR MIX WAS 30%; FLOW RATES ARE UNREPORTED. AN IN-LINE THERMOMETER WAS USED TO MONITOR THE PT'S TEMPERATURE WHEN REGULAR VENTILATOR CHECKS WERE MADE. IT IS UNREPORTED IT THE PT IS TRACHED. A PULMONARY SPECIALIST WAS CONSULTED. THERE WAS NO EFFECT ON THE PT. THE PT IS BEING TAKEN OFF THE VENTILATOR TODAY 11/5/97. THE HOSPITAL RECEIVED ON UPDATED MANUAL NOVEMBER 1995.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOR PHASE PLUS HUMIDIFIER HUMIDIFIER BTT SIMS/RESPIRATORY SUPPORT PRODUCTS, INC. 009300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other