BEUDAMED
    FDA Adverse Event Other Summary report: N

    AUTOSET SPIRIT - AMERICAS

    MDR report key: 1271476 · Received December 17, 2008

    Report

    Report Number
    3004604967-2008-00017
    Event Type
    Other
    Date Received
    December 17, 2008
    Date of Event
    November 18, 2008
    Report Date
    December 8, 2008
    Product Code
    BZD
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CUSTOMER'S (DME) INITIAL REQUEST FOR ROUTINE SERVICING, THE REPORT FOR "HEPA FILTER IS BLACK" WAS NOT CONFIRMED AS THE FILTER WAS NOT RETURNED TO RESMED. HOWEVER, RESMED TECHNICIAN PERFORMED ROUTINE INSPECTION (INTERNAL COMPONENTS OF THE DEVICE WERE INSPECTED, MOUNTED AND SECURED IN POSITION) AND RECORDED THAT HE OBSERVED PRESENCE OF GRAYISH MATERIAL ON MOTOR/BLOWER. UNIT IS SENT TO THE DESIGN HOUSE (RESMED LTD-(B) (4)) FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE DEVICE WAS INITIALLY FORWARDED TO RESMED FOR ROUTINE SERVICING WITH THE CUSTOMER (DME) COMMENT "HEPA FILTER IS BLACK". SUBSEQUENTLY, THE PT'S NURSE INFORMED RESMED THAT THE PT DEVELOPED A BLACK SPOT ON THEIR LUNG AND REQUESTED THAT THE GRAYISH MATERIAL FOUND ON THE UNIT DURING RESMED'S ROUTINE SERVICING BE ANALYSED, TO DETERMINE IF ITS RELATED TO THE BLACK SPOT FOUND ON PT'S LUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSET SPIRIT - AMERICAS AUTOSET SPIRIT - AMERICAS BZD 30001 141617

    Patients

    Seq Age Sex Outcome Treatment
    1