BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERIE EXTERNE ASTRAL

    MDR report key: 6019516 · Received October 11, 2016

    Report

    Report Number
    3004604967-2016-01100
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Report Date
    September 21, 2017
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASTRAL EXTERNAL BATTERY PACK WAS RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. PERFORMANCE TESTING CONFIRMED THE REPORT THAT THE EXTERNAL BATTERY BUTTON CANNOT BE COMPLETELY PRESSED DOWN TO CHECK THE BATTERY CHARGE CONDITION. THE INVESTIGATION DETERMINED THAT THE EXTERNAL BATTERY BUTTON FAILURE WAS MOST LIKELY DUE TO A DEFECTIVE BUTTON KEYPAD. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL EXTERNAL BATTERY PACK HAD A BROKEN BUTTON, THEREFORE, THE USER IS UNABLE TO CHECK THE BATTERY CHARGE CONDITION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL EXTERNAL BATTERY PACK HAD A BROKEN BUTTON, THEREFORE, THE USER IS UNABLE TO CHECK THE BATTERY CHARGE CONDITION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670694 BATTERIE EXTERNE ASTRAL CBK RESMED LTD 27918

    Patients

    Seq Age Sex Outcome Treatment
    1