BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESMED ASTRAL 150

    MDR report key: 9829074 · Received March 12, 2020

    Report

    Report Number
    MW5093732
    Event Type
    Death
    Date Received
    March 12, 2020
    Date of Event
    May 23, 2019
    Report Date
    March 12, 2020
    Manufacturer
    RESMED CORPORATION
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON A PLV100 VENTILATOR AND WAS SWITCHED TO A BRAND NEW VENTILATOR FROM RESUMED, THE ASTRAL 150. WITH THESE NEW VENTILATOR SINCE THE VOLUME IS LOUD, THEY TURN IT DOWN. ON (B)(6) 2019 WHILE THE PATIENT WAS RECEIVING HIS BREATHING TREATMENT, THE VOLUME OF THE ALARM WAS STILL TURNED DOWN. AFTER THE TREATMENT THE CAREGIVER LEFT THE PATIENT AND FORGOT TO TURN THE ALARM BACK ON. HE WAS ABOUT 150 FEET AWAY FROM THE PATIENT FOR ABOUT TWENTY (20) MINUTES. HE RETURNED AND FOUND THE PATIENT UNRESPONSIVE, HE RECONNECTED THE CIRCUIT IMMEDIATELY ON THE VENTILATOR AND CHECK THE BLOOD PRESSURE OF THE PATIENT, HE THEN BEGAN CPR WHILE SOMEONE ELSE CALLED THE PARAMEDICS (911) . THE CAREGIVER CONTINUED WITH THE CPR, WAS ABLE TO REVIVE THE PATIENT UNTIL THE PARAMEDICS ARRIVED AND TOOK HIM TO THE HOSPITAL. PATIENT WAS IN A COMA FOR SEVEN (7) WEEKS. AFTER FIVE (5) DAYS IN THE HOSPITAL, A GASTRIC TUBE WAS IMPLANTED FOR NUTRITION AND HYDRATION AND PATIENT WENT HOME . AFTER SIX (6) WEEKS AT HOME PATIENT PASSED AWAY ON (B)(6) 2019. REPORTER SPOKE WITH A RESPIRATORY THERAPIST AND SHE WAS INFORMED OF A NEW VENTILATOR MACHINE, NEW PORT HT70 THAT HAS AN ESCALATING ALARM TO ALERT CAREGIVERS IN CASE OF CRITICAL EMERGENCY. SHE BELIEVES IF RESMED ASTRAL 150 HAS THIS FEATURE, IT COULD HAVE SAVED HER HUSBAND¿S LIFE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER FOR REPORT MW5093732 ON 05/04/2020. REPORTER'S OCCUPATION IS A MEDICAL DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289809 RESMED ASTRAL 150 VENTILATOR, CONTINUOUS, (FACILITY/HOME) CBK RESMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death