BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED SWIFT

    MDR report key: 3041040 · Received July 18, 2007

    Report

    Report Number
    3004604967-2007-00006
    Event Type
    Injury
    Date Received
    July 18, 2007
    Date of Event
    September 9, 2006
    Report Date
    July 17, 2007
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K042403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "(B)(6) SUBMITTED A MEDWATCH REPORT ((B)(4)). THE (B)(6) RISK MANAGEMENT DIRECTOR REPORTED THAT A PT HAD COMPLAINED TO IT'S SLEEP LAB PERSONNEL OF BURNS ON THE FACE AT THE SITE OF ELECTRODES DURING THE COURSE OF A SLEEP STUDY. THE DIRECTOR ALSO NOTED AN INVESTIGATION CONCERNING THE DISINFECTANT USED TO STERILIZE THE EQUIPMENT. THE RISK MANAGEMENT DIRECTOR LATER SUBMITTED AN AMENDED MEDWATCH REPORT SPECULATING ABOUT THE POSSIBLE RELATIONSHIP BETWEEN THE PT'S BURNS AND THE POTENTIAL LOCATION OF THE HEAD STRAPS OF A RESMED MIRAGE SWIFT. SUBSEQUENTLY, AFTER CONTACT FROM THE PT'S ATTORNEY, RESMED BECAME AWARE THAT THE PT HAD SUFFERED SUPERFICIAL PARTIAL THICKNESS BURNS TO HER CHEEKS AFTER ELECTRODES WERE PLACED FOR A SLEEP STUDY. NEITHER THE SEPARATE ELECTRODES NOR THE DEVICE DESCRIBED AS A RESMED MIRAGE SWIFT WERE RETURNED FOR EVAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESMED SWIFT NASAL MASK BZD RESMED LTD. 60505 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other