BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - DEU

    MDR report key: 4834131 · Received June 4, 2015

    Report

    Report Number
    3007573469-2015-00183
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    RESMED LDT
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT A SYSTEM FAULT (SF180) ERROR MESSAGE OCCURRED ON AN ASTRAL DEVICE INDICATING A BATTERY CHARGER FAULT. THIS RESULTED IN AN ALARM WHICH NOTIFIED THE CAREGIVER OF THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #3004604967-2015-00183.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363483 ASTRAL 150 - DEU VENTILATOR, CONTINUOUS (FACILITY/HOME) CBK NOU RESMED LDT 27053

    Patients

    Seq Age Sex Outcome Treatment
    1