BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODKNIGHT 418S

    MDR report key: 754253 · Received October 28, 2005

    Report

    Report Number
    1222791-2005-00014
    Event Type
    Malfunction
    Date Received
    October 28, 2005
    Date of Event
    September 28, 2005
    Report Date
    October 25, 2005
    Manufacturer
    MALLINCKRODT DEVELOPMENT FRANCE
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TECHNICAL SERVICE SAID THE TRANSFORMER BURNT THROUGH THE COMPLETE BOTTOM CHASSIS, AND COMES OUT AT THE BOTTOM. OUR INVESTIGATION HAS SHOWN THAT THE TRANSFORMER OVERHEATED AND CAUSED THE PLASTIC PARTS TO MELT. THE EXTERNAL CASE IS NOT BURNT. A SHORT-CIRCUIT IN THE PRIMARY SECTION OF THE TRANSFORMER CAUSED THE CURRENT TO INCREASE, THUS LEADING TO THE OVERHEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 418S NASAL CPAP SYSTEM BYE MALLINCKRODT DEVELOPMENT FRANCE M-113513-DE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *