BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - FUKUDA

    MDR report key: 11465041 · Received March 11, 2021

    Report

    Report Number
    3004604967-2021-00381
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 8, 2021
    Report Date
    May 7, 2021
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498270934
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, AN INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO A SOFTWARE ISSUE RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: PR 2220020.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER AND AN EVALUATION CONFIRMED THE COMPLAINT. THE TOP CASE WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365063 ASTRAL 150 - FUKUDA CBK RESMED LTD 27093 00619498270934

    Patients

    Seq Age Sex Outcome Treatment
    1