BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODKNIGHT 425 ST

    MDR report key: 887750 · Received August 1, 2007

    Report

    Report Number
    9615679-2007-00005
    Event Type
    Malfunction
    Date Received
    August 1, 2007
    Date of Event
    July 2, 2007
    Report Date
    July 30, 2007
    Manufacturer
    NANCY
    Product Code
    BZD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A HUMIDIFIER WAS USED AND THAT THE UNIT WAS PLUGGED INTO A POWER STRIP. FAILURE INVESTIGATION SHOWS THAT A LIQUID, WATER, WAS SPILLED ONTO THE UNIT CAUSING A SHORT CIRCUIT.

    Description of Event or Problem · 1

    NFB RECEIVED A REPORT THAT ALLEGES A 425 BI-LEVEL UNIT "BURNED" INSIDE AND THAT THE ADAPTOR PLUG END CONNECTED TO THE UNIT MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 425 ST GOODKNIGHT BZD NANCY 425ST NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR