BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 100 - EUR1

    MDR report key: 14465170 · Received May 21, 2022

    Report

    Report Number
    3007573469-2022-00357
    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
    Product Problem
    Yes
    Report Source
    Distributor 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
    323683 ASTRAL 100 - EUR1 CBK RESMED LTD 27011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown