BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - APAC

    MDR report key: 5002409 · Received August 13, 2015

    Report

    Report Number
    3004604967-2015-00343
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 16, 2015
    Report Date
    December 16, 2015
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY LOCATED IN (B)(4) FOR INVESTIGATION. THE INVESTIGATION WAS UNABLE TO REPLICATE THE FAULT UNDER NORMAL USE CONDITIONS. THE DEVICE PERFORMED TO SPECIFICATIONS IN ALL ASPECTS. THE DEVICE WAS CLEANED, SERVICED, CALIBRATED, AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE RESMED TECHNICAL SERVICE CENTER FOR EVALUATION. THE REPORTED SYSTEM FAULT 101 COULD NOT BE REPRODUCED DURING THE EVALUATION. FURTHER INVESTIGATION DETERMINED THAT THE SYSTEM FAULT 101 WAS MOST LIKELY TRIGGERED DUE TO THE USER INCORRECTLY INSTALLING THE EXPIRATORY ADAPTER, CAUSING A SLIGHT LEAK IN THE CIRCUIT AS WELL AS WATER CONTAMINATION TO THE EXPIRATORY PRESSURE SENSOR INLET. BASED ON ALL AVAILABLE EVIDENCE, IT APPEARS THE USER DISCONNECTED THE CIRCUIT DURING THIS SITUATION, CAUSING THE SYSTEM FAULT 101 TO GENERATE. 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 LTD THAT A SYSTEM FAULT (SF101) WAS OBSERVED ON AN ASTRAL DEVICE INDICATING THAT THE OUTLET PRESSURE MEASUREMENT MAY BE INCORRECT. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534678 ASTRAL 150 - APAC VENTILATOR,CONTINUOUS(FACILITY/HOME) NOU RESMED LTD 27083

    Patients

    Seq Age Sex Outcome Treatment
    1