BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - APAC2

    MDR report key: 9567056 · Received January 8, 2020

    Report

    Report Number
    3007573469-2020-00037
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE NON-RETURN VALVE (NRV) ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. RESMED REFERENCE #: (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 THAT AN ASTRAL DEVICE FAILED TO COMPLETE ITS INTERNAL SELF-TEST. 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
    29940 ASTRAL 100 - APAC2 CBK RESMED LTD 27082

    Patients

    Seq Age Sex Outcome Treatment
    1