BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 DLB KIT FRA

    MDR report key: 4528165 · Received February 11, 2015

    Report

    Report Number
    3004604967-2015-00034
    Event Type
    Malfunction
    Date Received
    February 11, 2015
    Manufacturer
    RESMED LTD.
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    AN ENGINEERING INVESTIGATION WAS PERFORMED ON THE RETURNED ASTRAL DEVICE. THE INVESTIGATION DETERMINED THE ALARM WAS DUE TO HARDWARE DAMAGE OBTAINED FORM POWER SURGE CAUSED BY AN ELECTRICAL STORM (LIGHTENING STRIKE). RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PT INJURY REPORTED FOR THIS INCIDENT. (B)(4).

    Description of Event or Problem · 1

    REF IMPORT REPORT #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100090 ASTRAL 150 DLB KIT FRA VENTILATOR, CONTINUOUS (FACILITY/HOME); NOU, CBK NOU RESMED LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1