BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 SGL KIT - FRA

    MDR report key: 4850196 · Received June 11, 2015

    Report

    Report Number
    3007573469-2015-00196
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 11, 2015
    Manufacturer
    RESMED LRD
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B)(4) THAT A LOW BATTERY INDICATOR WAS DISPLAYED IN AN ASTRAL DEVICE EVEN THOUGH THE BATTERY IS FULLY CHARGED. THERE WAS NO PT HARM OR INJURY REPORTED AS A RESULT OF THIS INCIDENT. MFR #: 3004604967-2015-00196.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381022 ASTRAL 100 SGL KIT - FRA NOU, CBK NOU RESMED LRD 27072

    Patients

    Seq Age Sex Outcome Treatment
    1