BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSENSE 10 AUTOSET USA TRI

    MDR report key: 8844120 · Received July 30, 2019

    Report

    Report Number
    3007573469-2019-00246
    Event Type
    Injury
    Date Received
    July 30, 2019
    Report Date
    September 27, 2019
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    UDI-DI
    00619498372089
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE AIRSENSE 10 AUTOSET DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. THE INVESTIGATION DETERMINED THE DEVICE AND PSU WERE PERFORMING TO SPECIFICATIONS. VISUAL INSPECTION OF THE AC CABLE REVEALED THERMAL DAMAGE. TESTING OF THE AC CABLE DETERMINED IT IS ELECTRICALLY SOUND AND HAS NOT SHORTED. THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS DUE TO AN EXTERNAL HEAT SOURCE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET CAUGHT FIRE WHILE IN USE ON A PATIENT. IT WAS REPORTED THE PATIENT SOUGHT MEDICAL EVALUATION AT THE HOSPITAL FOR POSSIBLE SMOKE INHALATION (NO BURNS REPORTED) AND HAS RECOVERED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING RETURNED TO RESMED FOR AN ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. WHEN MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED REFERENCE #: PR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN AIRSENSE 10 AUTOSET CAUGHT FIRE WHILE IN USE ON A PATIENT. IT WAS REPORTED THE PATIENT SOUGHT MEDICAL EVALUATION AT THE HOSPITAL FOR POSSIBLE SMOKE INHALATION (NO BURNS REPORTED) AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634736 AIRSENSE 10 AUTOSET USA TRI BZD RESMED LTD 37208 00619498372089

    Patients

    Seq Age Sex Outcome Treatment
    1