BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRAL 150 DBL KIT FRA

    MDR report key: 18340585 · Received December 15, 2023

    Report

    Report Number
    3004604967-2023-00685
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    September 25, 2023
    Report Date
    December 15, 2023
    Manufacturer
    RESMED CORP
    Product Code
    NOU
    PMA / PMN Number
    K172875
    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 CONFIRMED THE REPORTED COMPLAINT. VISUAL INSPECTION OF THE THERMISTOR CABLE REVEALED PHYSICAL DAMAGE. DEVICE WAS SCRAPPED DUE TO CUSTOMER DECLINED REPAIR. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, AN INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO PHYSICAL DAMAGE OF THE THERMISTOR CABLE. 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 DISPLAYED AN ERROR MESSAGE (SF116) RELATED TO AMBIENT TEMPERATURE MEASUREMENT. 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
    1041735 ASTRAL 150 DBL KIT FRA VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED CORP 27074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown