BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 3150133 · Received April 30, 2013

    Report

    Report Number
    3004604967-2013-00016
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 30, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS EXAMINED OUR DEVICE TRACKING SYSTEM AND IDENTIFIED THE CUSTOMER THIS DEVICE WAS SOLD TO IN 2007. RESMED HAS CONTACTED THE CUSTOMER TO REQUEST THE DEVICE BE RETURNED, SO AN ENGINEERING INVESTIGATION COULD BE PERFORMED. TO DATE, THE CUSTOMER HAS NOT RESPONDED TO RESMED. SINCE THE DEVICE HAS NOT YET BEEN RETURNED, RESMED 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.

    Description of Event or Problem · 1

    RESMED RECEIVED REPORT (B)(4), FROM THE FDA REGARDING AN S8 DEVICE THAT CAUGHT FIRE. AS REPORTED IN (B)(4), THE CALLER STATED THAT WHILE HE WAS USING HIS SLEEP APNEA MACHINE FOR APPROX 4 HOURS, HE WAS AWAKENED BY SMOKE EMITTING FROM THE MASK. HE NOTICED THAT THERE WERE FLAMES ERUPTING FROM THE REAR OF THE UNIT. HE IMMEDIATELY UNPLUGGED IT TO CONTAIN THE FIRE. THE UNIT WAS SCORCHED AND DURING THE INCIDENT, HE WAS ABLE TO INHALE THE SMOKE. HE CONTACTED THE FIRE DEPARTMENT TO REPORT THE INCIDENT AS WELL. THE MFR WAS NOT CONTACTED YET. THE CALLER WAS ADVISED BY THE FIRE DEPARTMENT TO FILE A REPORT WITH THE AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186465 S8 ELITE - AMERICAS BZD RESMED LTD. 33021

    Patients

    Seq Age Sex Outcome Treatment
    1