BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLAR 150 GERMANY (GMBH)

    MDR report key: 8238176 · Received January 10, 2019

    Report

    Report Number
    3004604967-2019-00041
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Report Date
    March 22, 2019
    Manufacturer
    RESMED LTD
    Product Code
    MNT
    PMA / PMN Number
    K122715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE STELLAR DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED COMPLAINT AND REVEALED AN ERROR MESSAGE (SF25) RELATED TO THE INTERNAL BATTERY. PERFORMANCE TESTING CONFIRMED THE BATTERY DOES NOT CHARGE. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE REPORTED COMPLAINT. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS DUE TO A FAULTY INTERNAL BATTERY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. PER THE STELLAR USER GUIDE, (CONTRAINDICATION): THE STELLAR IS CONTRAINDICATED IN PATIENTS WHO ARE UNABLE TO ENDURE MORE THAN BRIEF INTERRUPTIONS IN VENTILATION. THE STELLAR IS NOT A LIFE SUPPORT VENTILATOR. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT A STELLAR DEVICE POWERED OFF WITHOUT ALARMING DURING A VISIT WITH THE DOCTOR. IT WAS REPORTED THAT THE PATIENT'S STATE OF HEALTH DETERIORATED AND THE DOCTOR CALLED AN AMBULANCE TO TAKE THE PATIENT TO THE HOSPITAL. NO FURTHER IMPAIRMENT OF HEALTH WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE STELLAR DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. THE INVESTIGATION METHODS, RESULTS AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. WHEN MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER THE STELLAR USER GUIDE, (CONTRAINDICATION): THE STELLAR IS CONTRAINDICATED IN PATIENTS WHO ARE UNABLE TO ENDURE MORE THAN BRIEF INTERRUPTIONS IN VENTILATION. THE STELLAR IS NOT A LIFE SUPPORT VENTILATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A STELLAR DEVICE POWERED OFF WITHOUT ALARMING DURING A VISIT WITH THE DOCTOR. IT WAS REPORTED THAT THE PATIENT'S STATE OF HEALTH DETERIORATED AND THE DOCTOR CALLED AN AMBULANCE TO TAKE THE PATIENT TO THE HOSPITAL. NO FURTHER IMPAIRMENT OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26926 STELLAR 150 GERMANY (GMBH) MNT RESMED LTD 24141

    Patients

    Seq Age Sex Outcome Treatment
    1