BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - FUKUDA

    MDR report key: 6153070 · Received December 7, 2016

    Report

    Report Number
    3004604967-2016-01308
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    April 4, 2017
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE ASTRAL DEVICE WAS RETURNED TO RESMED AND AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS REVEALED THE OCCURRENCES OF SYSTEM FAULT ERROR MESSAGES (SF 131, 101, 218 AND 74). PERFORMANCE TESTING DID NOT REPRODUCE THE SYSTEM FAULT ERRORS. THE INVESTIGATION DETERMINED THAT THE DEVICE EVENTS WERE MOST LIKELY DUE TO WATER CONTAMINATION. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF218). 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 DEVICE DISPLAYED AN ERROR MESSAGE (SF218). THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801016 ASTRAL 150 - FUKUDA NOU RESMED LTD 27093

    Patients

    Seq Age Sex Outcome Treatment
    1