BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 COMPACT - AMERICAS

    MDR report key: 6001301 · Received October 5, 2016

    Report

    Report Number
    3004604967-2016-01082
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K033841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS ATTEMPTED TO MAKE CONTACT WITH THE PATIENT FOR FURTHER INFORMATION REGARDING THE DEVICE AND THE REPORTED EVENT HOWEVER, THE PATIENT HAS NOT RESPONDED. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    RESMED RECEIVED A LETTER FROM THE FDA REGARDING A MEDWATCH (MW5064397) SUBMITTED BY A PATIENT. PER THE REPORT, A RESMED S8 CPAP MALFUNCTIONED AND FLAMES APPEARED AT THE BACK OF THE MACHINE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653423 S8 COMPACT - AMERICAS BZD RESMED LTD 33030

    Patients

    Seq Age Sex Outcome Treatment
    1