BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODKNIGHT 418A

    MDR report key: 617636 · Received July 29, 2004

    Report

    Report Number
    9615679-2004-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2004
    Date of Event
    July 13, 2004
    Report Date
    July 27, 2004
    Manufacturer
    MALLINCKRODT DEVELOPPEMENT FRANCE
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN PT WOKE UP AFTER USAGE OF ITS GOODKNIGHT 418A CPAP SYSTEM FOR 10 HOURS, THEY NOTICED AN ODOR OF BURN. UNIT WAS RETURNED TO TECHNICAL SERVICES. OUR INVESTIGATION HAS SHOWN THAT THE TRANSFORMER OVERHEATED AND CAUSED THE PLASTIC PARTS TO MELT. 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 418A NASAL CPAP SYSTEM BYE MALLINCKRODT DEVELOPPEMENT FRANCE M-113501-00 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *