BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S8 AUTOSET SPIRIT II UK

    MDR report key: 2323482 · Received October 28, 2011

    Report

    Report Number
    3004604967-2011-00054
    Event Type
    Injury
    Date Received
    October 28, 2011
    Date of Event
    September 1, 2011
    Report Date
    October 28, 2011
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K071171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT DID NOT SEEK MEDICAL ATTENTION. RESMED LTD PERFORMED AN ENGINEERING INVESTIGATION FOUND THE METAL CRIMPING PIN THAT HOLDS THE CONDUCTIVE PORTION OF THE POWER CORD WIRE IN PLACE WAS BROKEN OFF. THIS CAUSED POOR ELECTRICAL CONTACT WHICH LED TO ARCING THAT OVERHEATED THE AC CONNECTOR'S INSULATION. THE MOST LIKELY CAUSE OF THE BROKEN PIN OF THE POWER CORD AC CONNECTOR WAS A BENDING FORCE APPLIED AT THE JOIN OF THE CRIMPING PIN AND THE WIRE WHICH APPEARS TO BE THE MOST VULNERABLE SITE IN THIS POWER CORD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT AN S8 AUTOSET SPIRIT II DEVICE WAS SMOKING AT THE POWER CORD. AROUND 6AM, THE PT WAS WOKEN UP WHEN THEY REPORTEDLY HAD DIFFICULTY BREATHING AND FOUND SPARKS AND SMOKE COMING FROM THEIR DEVICE WHERE THE POWER CORD CONNECTS TO THE MACHINE. THE PT MANAGED TO UNPLUG THE MACHINE FROM THE MAIN POWER SUPPLY. THE PT ALLEGES SHE SOON COLLAPSED THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 AUTOSET SPIRIT II UK BZD RESMED LTD 33146

    Patients

    Seq Age Sex Outcome Treatment
    1 Other