BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRAL 100 - APAC2

    MDR report key: 18293580 · Received December 8, 2023

    Report

    Report Number
    3004604967-2023-00675
    Event Type
    Injury
    Date Received
    December 8, 2023
    Date of Event
    July 19, 2023
    Report Date
    April 9, 2024
    Manufacturer
    RESMED PTY LTD
    Product Code
    NOU
    PMA / PMN Number
    K172875
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED NO ABNORMAL FINDINGS. THE INVESTIGATION DETERMINED THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS PERFORMING TO SPECIFICATIONS. PER CLINICAL ASSESSMENT, THERE IS CURRENTLY NO INDICATION TO SUGGEST A DEVICE MALFUNCTION HAD OCCURRED AND CAUSED OR CONTRIBUTED TO THE PATIENT¿S REPORTED CARDIAC INCIDENT AND SUBSEQUENT DEATH 2 MONTHS AFTER. ASTRAL 100/150 USER GUIDE PROVIDE THE FOLLOWING WARNING: - ¿REPORT UNUSUAL CHEST PAIN, SEVERE HEADACHE OR INCREASED BREATHLESSNESS TO YOUR PHYSICIAN.¿ ASTRAL 100/150 USER GUIDE ALSO WARNS: - ¿IF YOU NOTICE ANY UNEXPLAINED CHANGES IN THE PERFORMANCE OF THE DEVICE, IF IT IS MAKING UNUSUAL OR HARSH SOUNDS, IF THE DEVICE OR THE POWER SUPPLY ARE DROPPED OR MISHANDLED DISCONTINUE USE AND CONTACT YOUR HEALTHCARE PROVIDER.¿ RESMED¿S RISK ASSOCIATED WITH USE OF THE DEVICE REMAINS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Additional Manufacturer Narrative · 0

    RESMED HAS REQUESTED FOR THE ASTRAL DEVICE AND THE DEVICE USAGE RECORDS TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED, HOWEVER, THE DEVICE OR THE DEVICE USAGE RECORDS HAVE NOT BEEN RETURNED TO RESMED. REVIEW OF THE DEVICE USAGE RECORDS BY A THIRD-PARTY SERVICER REVEALED NO ABNORMAL FINDINGS, INCLUDING ON THE DATE OF CARDIAC ARREST. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT IN (B)(6) 2023, A PATIENT EXPERIENCED CARDIAC ARREST WHILE USING AN ASTRAL 100 DEVICE IN WHICH ALLEGEDLY THE "AIR PUMP STOPPED WORKING" AND ALARMS WERE INAUDIBLE. PATIENT'S DAUGHTER REPORTED THAT AFTER SHE REPLACED THE CIRCUIT OF THE DEVICE, THE DEVICE RESUMED NORMAL OPERATION. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY EXPIRED IN (B)(6) 2023 WHILE USING AN UNKNOWN DEVICE. PATIENT'S CAUSE OF DEATH HAS NOT BEEN DISCLOSED TO RESMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT IN (B)(6) 2023, A PATIENT EXPERIENCED CARDIAC ARREST WHILE USING AN ASTRAL 100 DEVICE IN WHICH ALLEGEDLY THE "AIR PUMP STOPPED WORKING" AND ALARMS WERE INAUDIBLE. PATIENT'S DAUGHTER REPORTED THAT AFTER SHE REPLACED THE CIRCUIT OF THE DEVICE, THE DEVICE RESUMED NORMAL OPERATION. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY EXPIRED IN OCTOBER 2023 WHILE USING AN UNKNOWN DEVICE. PATIENT'S CAUSE OF DEATH HAS NOT BEEN DISCLOSED TO RESMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781978 ASTRAL 100 - APAC2 VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED PTY LTD 27082

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female