BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - AMER

    MDR report key: 9579567 · Received January 12, 2020

    Report

    Report Number
    3004604967-2020-00126
    Event Type
    Malfunction
    Date Received
    January 12, 2020
    Report Date
    January 12, 2020
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498270019
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO RESMED FOR AN EVALUATION. A RESMED CUSTOMER REPRESENTATIVE ASSISTED THE CUSTOMER WITH INSTRUCTIONS TO PERFORM A HARD RESET OF THE DEVICE. (B)(4). REPORT LATE DUE TO TRANSITION FROM VMSR PROGRAM. ESTABLISHMENT WAS UNAWARE OF FDA LETTER DATED 16 SEPTEMBER 2019 FOR CBK PROCODE STATUS CHANGE IN VMSR PROGRAM UNTIL NOTIFIED DIRECTLY BY FDA ON 18 DECEMBER 2019 FOLLOWING SUBMISSION OF OUR QUARTERLY SUMMARY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED 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
    42706 ASTRAL 100 - AMER CBK RESMED LTD 27001 00619498270019

    Patients

    Seq Age Sex Outcome Treatment
    1