BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLIED HEALTHCARE PRODUCTS, INC.

    MDR report key: 77904 · Received February 28, 1997

    Report

    Report Number
    77904
    Event Type
    Malfunction
    Date Received
    February 28, 1997
    Date of Event
    November 15, 1996
    Report Date
    January 13, 1997
    Manufacturer
    ALLIED HEALTHCARE PRODUCTS, INC.
    Product Code
    BYL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE MIST TENT IS SET-UP PER MFR'S RECOMMENDATIONS A STATIC PROBLEM IS PRESENT. WITH THE UNIT PROPERLY SET-UP AND RUNNING, IF ONE HOLDS THE THREE OUTLET HOSES IN ONE HAND AND TOUCHES THE EQUIPMENT CHASIS WITH THE OTHER HAND ONE WILL RECEIVE A STATIC SHOCK. THIS WAS DUPLICATED BY THE MFR ON SITE AT HOSP. EQUIPMENT WAS NEVER USED ON PT. MFR'S ATTITUDE WAS THAT THIS PROBLEM WAS UNIQUE TO THIS INSTITUTION ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIED HEALTHCARE PRODUCTS, INC. O2/MIST TENT BYL ALLIED HEALTHCARE PRODUCTS, INC. 15100 CAM 4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other