BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASTRAL 150 - AMER

    MDR report key: 11904676 · Received May 28, 2021

    Report

    Report Number
    3007573469-2021-00643
    Event Type
    Death
    Date Received
    May 28, 2021
    Date of Event
    March 12, 2021
    Report Date
    March 25, 2024
    Manufacturer
    RESMED LTD
    Product Code
    NOU
    Report Source
    Distributor report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTER HAS REFUSED RESMED¿S AND THE DME PROVIDER¿S (LIFEHME) REQUESTS TO INSPECT AND DOWNLOAD DATA FROM THE VENTILATOR. RESMED REQUESTED A CLINICAL OPINION AS TO THE CAUSE(S) OF THE PATIENT¿S DEATH, BUT THE CAUSES(S) COULD NOT BE IDENTIFIED. THE CLINICAL OPINION FOUND THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THERE WAS A DEVICE MALFUNCTION OR IF THERE WERE CHANGES IN THE PATIENT¿S CONDITION THAT COULD HAVE RESULTED IN THE PATIENT¿S REPORTED DEATH. RESMED HAS LEARNED FROM THE DME PROVIDER WHO SUPPLIED AND SERVICED THE VENTILATOR TO PLAINTIFF THAT THE DME PROVIDER PURCHASED THE VENTILATOR FROM RESMED ON (B)(6) 2019. THE DME PROVIDER PROVIDED THE VENTILATOR TO THE CHILD ON (B)(6) 2020. THE VENTILATOR WAS SERVICED ONCE, ON (B)(6) 2020 AND SHIPPED THE VENTILATOR BACK TO THE CHILD¿S FAMILY THE SAME DAY. THE DME PROVIDER LAST SAW THE VENTILATOR ON 2/12/21. IT HAD 5443 PATIENT HOURS ON THAT DAY. RESMED REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON MARCH 11, 2021, MOTHER OF PATIENT NOTICED THE RESMED VENTILATOR WAS BEEPING, SO SHE CHECKED THE HOSES, FILTERS, AND CORDS TO SEE IF IT WAS ANYTHING SHE COULD FIX. THE MOTHER WAS UNABLE TO IDENTIFY THE CAUSE(S) OF THE BEEPING. AT 9:00 A.M. PATIENT¿S MOTHER INFORMED THE NURSE ABOUT THE VENTILATOR BEEPING ISSUES SHE HAD EARLIER THAT MORNING. BY THIS TIME THE BEEPING HAD STOPPED. AT AROUND 11 A.M. THE VENTILATOR APPEARED TO THE MOTHER TO BE WORKING NORMALLY, AND THERE WAS NO BEEPING. SOMETIME AFTER THAT, THE NURSE CALLED PATIENT¿S MOTHER AND LET HER KNOW THAT THE VENTILATOR HAD BEGUN BEEPING AGAIN AND SUGGESTED THE SERVICE PROVIDER, LIFEHME, BE CONTACTED. THERE IS NO INDICATION THAT THE NURSE WAS ABLE TO IDENTIFY THE CAUSE(S) OF THE BEEPING. AROUND 2 P.M. PATIENT¿S MOTHER CALLED LIFEHME TO SEE IF THE SOMEONE COULD CHECK ON THE VENTILATOR. DURING THE NIGHT, PATIENT¿S MOTHER NOTICED VIA BABY CAMERA THAT THE MACHINE HAD BEGUN BEEPING AGAIN. THROUGHOUT THE NIGHT, PATIENT¿S MOTHER CHECKED THE VENTILATOR AS MUCH AS POSSIBLE AS THE BEEPING BECAME MORE FREQUENT. APPARENTLY, SHE WAS STILL UNABLE TO DETERMINE WHY THE VENTILATOR WAS BEEPING. ON (B)(6) 2021, PATIENT¿S MOTHER CHECKED ON PATIENT WHO WAS SLEEPING AND APPEARED TO BE IN DISCOMFORT. AT 8 A.M. THE VENTILATOR BEGAN BEEPING MORE OFTEN. AROUND 10 A.M. PATIENT¿S MOTHER NOTICED PATIENT¿S STOMACH WAS NOT MOVING. PATIENT¿S MOTHER BEGAN TO UNHOOK THE VENTILATOR TO DO CPR AND NOTICED THERE WAS NO AIR COMING OUT OF IT. PATIENT¿S MOTHER CONTINUED TO PERFORM CPR AND CONFIRMED PATIENT WAS PULSELESS VIA PULSE MONITOR. EMERGENCY MEDICAL SERVICES ARRIVED AND TOOK OVER CPR. MEDICAL EXAMINER CONFIRMED PATIENT¿S DEATH.

    Additional Manufacturer Narrative · 1

    THE REPORTER HAS NOT RESPONDED TO REQUESTS FOR ADDITIONAL INFORMATION FOR THE DEVICE FOR INVESTIGATION. RESMED REFERENCE #:(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT THERE WAS A PATIENT DEATH ALLEGEDLY AS A RESULT OF EQUIPMENT MADE BY RESMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801386 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD
    801398 ASTRAL 150 - AMER VENTILATOR, CONTINUOUS (FACILITY/HOME) NOU RESMED LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Unknown Death