BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S9 VPAP S - AM

    MDR report key: 3099839 · Received April 30, 2013

    Report

    Report Number
    3004604967-2013-00014
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K102513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RECENTLY RETURNED TO RESMED CORP LOCATED IN (B)(4). A PRELIMINARY EVALUATION WAS PERFORMED WHICH CONFIRMED HEAT DAMAGE TO THE DEVICE. THE DEVICE IS CURRENTLY BEING RETURNED TO THE MANUFACTURER, RESMED LTD IN (B)(6) FOR A COMPLETE FAILURE INVESTIGATION. RESMED WILL PROVIDE A FOLLOW-UP REPORT ONCE THE ROOT CAUSE INVESTIGATION HAS BEEN COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY REPORTED FOR THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT THE S9 VPAP S DEVICE CAUGHT FIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187235 S9 VPAP S - AM BZD RESMED LTD. 36004A

    Patients

    Seq Age Sex Outcome Treatment
    1