BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRCURVE 10 CS-A TJ

    MDR report key: 17000082 · Received May 24, 2023

    Report

    Report Number
    3007573469-2023-00370
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 21, 2023
    Report Date
    July 19, 2023
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    UDI-DI
    00619498282807
    Report Source
    Distributor report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED OUTSIDE THE US. DURING A ROUTINE CHECK OF COMPLAINTS RECORDS IT WAS DETECTED THAT THE DEVICE AIRCURVE 10 CS-A INVOLVED IN THE EVENT IS NOT MARKETED IN THE UNITED STATES. THE AIRCURVE 10 CS-A DEVICE (OR SIMILAR DEVICE) HAS NOT BEEN CLEARED OR APPROVED FOR USE IN THE U.S. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTABILITY REQUIREMENTS AS DESCRIBED IN SECTION 21 CFR 803.50. THIS REPORT IS BEING SUBMITTED TO CORRECT THE ERROR. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. VISUAL INSPECTION CONFIRMED THE DEVICE WAS FLOODED WITH WATER. REVIEW OF THE DEVICE LOGS CONFIRMED ERROR 021 AND REVEALED THE DEVICE DISPLAYED 'PRESSURE SENSOR DUAL CHECK FAILED' ALARM. TRIGGER OF THE ALARM CAUSES THERAPY TO STOP UNTIL THE ALARM IS DEACTIVATED. THE AIRCURVE 10 CS-A USER GUIDE PROVIDES THE FOLLOWING INDICATIONS FOR USE: - ¿THE AIRCURVE 10 CS-A IS INTENDED TO USE FOR ASSISTING RESPIRATION OF SPONTANEOUSLY BREATHING PATIENTS WITH A WEIGHT GREATER THAN 30 KG AT MEDICAL FACILITIES AND HOME USE.¿ IT IS ONLY INTENDED TO PROVIDE VENTILATION TO A SPONTANEOUSLY BREATHING PATIENTS AS IT IS NOT A LIFE SUPPORT VENTILATOR. IN THE EVENT OF DEVICE FAILURE, AN INDICATED PATIENT WOULD BE ABLE TO CONTINUE BREATHING SPONTANEOUSLY UNTIL AN ALTERNATIVE MEANS OF VENTILATION SUPPORT CAN BE PROVIDED. THE USER GUIDE ALSO PROVIDES THE FOLLOWING WARNING: - ¿THE DEVICE IS NOT SUITABLE FOR VENTILATOR DEPENDENT PATIENTS.¿ THE INVESTIGATION METHODS, RESULTS, AND CONCLUSION ARE NOT FINALIZED AT THIS STAGE. WHEN MORE INFORMATION IS AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT A PATIENT EXPERIENCED DETERIORATION OF RESPIRATORY CONDITION AND SUBSEQUENT CARDIOPULMONARY ARREST AFTER STARTING USE OF AN AIRCURVE 10 CS-A DEVICE TO ADDRESS WORSENING RESPIRATORY CONDITION. DEVICE HAD DISPLAYED AN ERROR 021. INITIAL INSPECTION OF THE DEVICE REVEALED THE DEVICE WAS FLOODED WITH WATER. PATIENT WAS PROVIDED LIFE-SAVING TREATMENT AND SWITCHED TO AN IN-HOSPITAL VENTILATOR. PATIENT'S CONDITION STABILIZED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT A PATIENT EXPERIENCED DETERIORATION OF RESPIRATORY CONDITION AND SUBSEQUENT CARDIOPULMONARY ARREST AFTER STARTING USE OF AN AIRCURVE 10 CS-A DEVICE TO ADDRESS WORSENING RESPIRATORY CONDITION. DEVICE HAD DISPLAYED AN ERROR 021. INITIAL INSPECTION OF THE DEVICE REVEALED THE DEVICE WAS FLOODED WITH WATER. PATIENT WAS PROVIDED LIFE-SAVING TREATMENT AND SWITCHED TO AN IN-HOSPITAL VENTILATOR. PATIENT'S CONDITION STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507468 AIRCURVE 10 CS-A TJ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED LTD 00619498282807

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female