BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - EUR1

    MDR report key: 14465523 · Received May 21, 2022

    Report

    Report Number
    3004604967-2022-00357
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    April 23, 2022
    Report Date
    June 23, 2022
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    PMA / PMN Number
    K172875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE NRV ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE#: (B)(4).

    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 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

    DURING EVALUATION BY AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER, THE NON-RETURN VALVE (NRV) ASSEMBLY WAS FAULTY. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 0

    DURING EVALUATION BY AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER, THE NON-RETURN VALVE (NRV) ASSEMBLY WAS FAULTY. 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
    323684 ASTRAL 100 - EUR1 CBK RESMED LTD 27011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown