BEUDAMED
    FDA Adverse Event Other Summary report: N

    HME BOOSTER

    MDR report key: 589028 · Received June 16, 2004

    Report

    Report Number
    1824226-2004-00001
    Event Type
    Other
    Date Received
    June 16, 2004
    Date of Event
    April 1, 2004
    Report Date
    June 15, 2004
    Manufacturer
    KING SYSTEMS CORP.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDSIZE HME-BOOSTER HEATING ELEMENT WAS FOUND TO BE EXTREMELY HOT TO TOUCH DURING THE CHECK. THERE WAS NO ADVERSE EVENT TO THE PT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HME BOOSTER HEATER BTT KING SYSTEMS CORP. MSB-600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other