BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H5I- ROW

    MDR report key: 3101831 · Received May 1, 2013

    Report

    Report Number
    3004604967-2013-00017
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    February 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K091947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED'S ENGINEERING INVESTIGATION DEPARTMENT HAS NOT REC'D THIS DEVICE AND THEREFORE IS UNABLE TO CONFIRM THE COMPLAINT OR DETERMINE THE CAUSE OF THE MALFUNCTION AT THIS TIME. RESMED IS NOT AWARE OF ANY PT INJURY REPORTED FOR THIS INCIDENT. NOTE: THIS COMPLAINT WAS ORIGINALLY INCORRECTLY ASSESSED AS BEING A NON-REPORTABLE EVENT. DURING A ROUTINE CHECK OF COMPLAINTS RECORDS THIS WAS DETECTED, AND THIS REPORT IS BEING SUBMITTED TO CORRECT THE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN H5I HUMIDIFIER HAS BURNT COMPONENTS ON THE PCB, ORANGE FLAMES WERE VISIBLE AND SMOKE WAS EMITTED WHERE A HOLE HAS BEEN BURNT THROUGH THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190796 H5I- ROW BZD RESMED LTD. 36905

    Patients

    Seq Age Sex Outcome Treatment
    1