BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - DEU

    MDR report key: 6062665 · Received October 27, 2016

    Report

    Report Number
    3004604967-2016-01173
    Event Type
    Malfunction
    Date Received
    October 27, 2016
    Report Date
    December 13, 2016
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K133868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE LOGS WERE RETURNED TO THE RESMED MANUFACTURING FACILITY FOR AN EXTENSIVE ENGINEERING INVESTIGATION. BASED ON THE INVESTIGATION AND PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS, IT WAS DETERMINED THAT THE REPORTED SYSTEM FAULT (SF 65) WAS DUE TO A SOFTWARE ISSUE. RESMED RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. THERE WAS NO PATIENT INJURY REPORTED FOR THIS INCIDENT. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION WAS PERFORMED. REVIEW OF THE DEVICE LOGS CONFIRMED A SINGLE OCCURRENCE OF SYSTEM FAULT 65. DEVICE TESTING DID NOT REPRODUCE THE REPORTED ISSUE AND THE EVALUATION RESULT WAS NO FAULT FOUND. THE DEVICE WAS SERVICED, CLEANED, CALIBRATED AND TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED'S RISK ANALYSIS FOR THESE FAILURE MODES CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE DISPLAYED AN ERROR MESSAGE (SF65) INDICATING DATA CORRUPTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712539 ASTRAL 150 - DEU CBK RESMED LTD 27053

    Patients

    Seq Age Sex Outcome Treatment
    1