BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 - FRA

    MDR report key: 13172194 · Received January 5, 2022

    Report

    Report Number
    3004604967-2022-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    November 30, 2021
    Report Date
    March 14, 2023
    Manufacturer
    RESMED LTD
    Product Code
    CBK
    UDI-DI
    00619498270736
    PMA / PMN Number
    K152068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION REVEALED THE TOUCHSCREEN WOULD NOT CALIBRATE AND NON-RETURN VALVE (NRV) WAS DEFECTIVE. THE TOP CASE AND NRV WERE 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

    THE DEVICE WAS RECEIVED BY RESMED AND AN EVALUATION REVEALED THE TOUCHSCREEN WOULD NOT CALIBRATE AND NON-RETURN VALVE (NRV) WAS DEFECTIVE. THE TOP CASE AND NRV WERE 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, THE INVESTIGATION DETERMINED THAT THE NRV WAS FAULTY/DEFECTIVE AND THE TOUCHSCREEN ISSUE WAS DUE TO A MANUFACTURING DEFECT. 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 HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. THERE WAS NO PATIENT HARM OR SERIOUS INJURY REPORTED AS A RESULT OF THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN ASTRAL DEVICE HAD AN UNRESPONSIVE TOUCHSCREEN. DURING DEVICE EVALUATION, THE NON-RETURN VALVE (NRV) WAS DETERMINED TO BE DEFECTIVE. 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
    77134 ASTRAL 150 - FRA Ventilator, continuous, facility use CBK RESMED LTD 27073 00619498270736

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown