BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - APAC2

    MDR report key: 11090874 · Received December 29, 2020

    Report

    Report Number
    3004604967-2020-01274
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Report Date
    February 26, 2021
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS NOT RETURNED TO RESMED. AN INVESTIGATION WAS PERFORMED ON ALL AVAILABLE INFORMATION. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO A FAULTY/DEFECTIVE NRV. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE CUSTOMER WAS ISSUED WITH A REPLACEMENT NON-RETURN VALVE (NRV) ASSEMBLY AS A PART OF A WARRANTY CLAIM. RESMED REFERENCE#: PR 2180922.

    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
    1550585 ASTRAL 150 - APAC2 CBK RESMED LTD 27088 1346853

    Patients

    Seq Age Sex Outcome Treatment
    1