BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S8 AUTOSET TEIJIN

    MDR report key: 4913244 · Received July 9, 2015

    Report

    Report Number
    3007573469-2015-00250
    Event Type
    Injury
    Date Received
    July 9, 2015
    Date of Event
    April 1, 2015
    Report Date
    July 9, 2015
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(6) THAT A PT WHO HAD RECENTLY UNDERGONE LUNG SURGERY WAS USING AN S8 AUTOSET AND DIAGNOSED WITH PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444827 S8 AUTOSET TEIJIN BZD RESMED LTD 33138

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization