BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODKNIGHT 418A

    MDR report key: 435276 · Received December 16, 2002

    Report

    Report Number
    9615679-2002-00001
    Event Type
    Malfunction
    Date Received
    December 16, 2002
    Date of Event
    October 7, 2002
    Report Date
    December 12, 2002
    Manufacturer
    MALLINCKRODT DEVELOPPEMENT FRANCE
    Product Code
    BYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    30 MINUTES AFTER STARTING USING THEIR GOODKNIGHT 418A NASAL CPAP SYSTEM, THE PATIENT WOKE UP AS A RESULT OF A STRONG SMELL. SMOKE WAS COMING OUT OF THE UNIT. THE PATIENT HAD TO PLUG OFF THE UNIT AND TAKE IT OUT OF THE HOUSE. THE COMPANY'S INVESTIGATION HAS SHOWN THAT THE TRANSFORMER OVERHEATED AND CAUSED THE PLASTIC PARTS TO MELT. A SHORT-CIRCUIT IN THE PRIMARY SECTION OF THE TRANSFER CAUSED THE CURRENT TO INCREASE, THUS LEADING TO THE OVERHEAT. HOWEVER, THE CURRENT WAS NOT HIGH ENOUGH TO HAVE THE FUSE OPENING QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 418A NASAL CPAP SYSTEM BYE MALLINCKRODT DEVELOPPEMENT FRANCE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN