BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTELLIPAP AUTO BILEVEL W/HEATED HUMIDIFIER

    MDR report key: 21807098 · Received April 9, 2025

    Report

    Report Number
    3009096682-2025-00003
    Event Type
    Death
    Date Received
    April 9, 2025
    Date of Event
    February 22, 2025
    Report Date
    March 12, 2025
    Manufacturer
    DEVILBISS HEALTHCARE, LLC
    Product Code
    BZD
    PMA / PMN Number
    K091919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REACT HEALTH HAD PREVIOUSLY SUBMITTED A REPORT STATING THAT A PATIENT HAD DIED WHILE USING A DEVILBISS INTELLIPAP BIPAP. ADDITIONAL INFORMATION WAS RECEIVED ON 4/15/2025 FROM THE HOSPICE PROVIDER ON A PATIENT COMPLAINT FORM. THE HOSPICE PROVIDER ALSO FORWARDED A SERVICE REPORT FROM A THIRD PARTY SERVICE PROVIDER. PER THEIR PAPERWORK, IT WAS NOTED THE STREETS DME LLC MEDICAL DELIVERY TECHNICIAN WHO HAD DELIVERED THE BIPAP ON 2/20/2025 WITH ALL SUPPLIES (MASK, PRESSURE LINE ADAPTOR AND GREY CORRUGATED TUBING) NOTICED THE PATIENT HAD THEIR OWN 5 LITER AND 10 LITER CONCENTRATOR AND ALSO A PHILIPS RESPIRONICS TRILOGY WITH BLUE TUBING. ON 2/24/2025 THE DELIVERY TECHNICIAN PICKED UP ALL EQUIPMENT DUE TO PATIENT PASSING AND NOTICED THEIR BLUE TUBING FROM THE PHILIPS RESPIRONICS TRILOGY WAS ON THE DEVILBISS BIPAP, # (B)(6). THE BIPAP, (B)(6) WAS TESTED BY THE EQUIPMENT PROVIDER ON THE SAME DAY OF THE COMPLAINT WITH NO ISSUES FOUND. THE AIR PRESSURE WAS NORMAL. THE DEVICE WAS THEN SENT TO MEDICAL TECTRONICS, INC. IN HOUSTON, TEXAS FOR A PERFORMANCE EVALUATION. THE TECHNICIAN RAN FULL DIAGNOSTICS ON UNIT UPON INTAKE AND INDICATED NO ISSUES. THE UNIT WAS STATED AS OPERATING ACCORDING TO MANUFACTURER'S SPECIFICATIONS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO HAVE THE DEVICE RETURNED TO REACT HEALTH FOR EVALUATION AND THE DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 0

    REACT HEALTH RECEIVED A COMPLAINT FROM DEVILBISS HEALTHCARE, LLC BY EMAIL ON (B)(6) 2025 STATING THAT A PATIENT WAS IN HOSPICE CARE AND PASSED AWAY WHILE USING THE DEVILBISS INTELLIPAP DEVICE. THE PATIENT'S DAUGHTER ALLEGES THAT THE CPAP TUBING BECAME DISCONNECTED FROM THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO REACT HEALTH AS OF THIS REPORT. REACT HEALTH IS FILING AN INITIAL REPORT. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    FROM DEVILBISS COMPLAINT RECEIVED BY EMAIL: "I WOULD LIKE TO FILE A COMPLAINT CONCERNING A MEDICAL DEVICE. ON (B)(6) 2025, MY MOTHER WAS PUT ON HOSPICE. SHE WAS DISCHARGED FROM THE HOSPITAL AND WENT HOME AS BIPAP DEPENDENT. MY MOTHER HAD COPD AND THOUGH SHE WAS PUT ON HOSPICE SHE WAS NO WHERE NEAR READY TO PASS. MY MOTHER ATE DINNER ON FRIDAY NIGHT, SHE GOT UP BY HERSELF, USED THE RESTROOM AND WAS FULLY ALLERT. SHE WENT TO SLEEP THAT NIGHT AT 1045PM AND WOKE UP SOMETIME BETWEEN 530 AND 6AM. AT THIS TIME MY MOTHER SAT UP IN HER BED AND WHEN DOING SO HER BIPAP TUBE CAME COMPLETELY OFF OF HER MACHINE. ONCE THIS HAPPENED SHE WAS UNABLE TO REATTACH IT AND I WAS TOO LATE GETTING TO HER. THE MASK WAS STILL FULLY ATTACHED TO HER FACE BUT THE END THAT ATTACHES TO THE BIPAP MACHINE CAME LOOSE. I HAD NO IDEA THAT COULD HAPPEN OR I WOULD HAVE STAYED WHERE I COULD WATCH HER EVERY SECOND OF THE DAY. THE MACHINE HAS NO EJECTION PORT, NO ALARM AND JUST SLIDES RIGHT OFF THE MACHINE. I WAS TOO LATE, BY THE TIME I GOT TO MY MOTHER SHE COULD NOT CATCH HER BREATH AND DIED AT 642AM. MY MOTHER DIED BECAUSE OF THIS MACHINES FAILURE MY MOTHER SUFFERED AND DIED A HORRIBLE DEATH. SOMETHING NEEDS TO BE DONE TO MAKE THESE MACHINES SAFE FOR PEOPLE THAT ARE DEPENDENT UPON THEM. THE SIMPLE SLIDING ON AND OFF IS NOT SAFE AND KILLS PEOPLE WHO ARE DEPENDENT UPON THESE MACHINES. THE MACHINE SHE WAS USING: DEVILBISS INTELLIPAP." SEE DEVILBISS COMPLAINT# (B)(4). MW5168016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470441 INTELLIPAP AUTO BILEVEL W/HEATED HUMIDIFIER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD DEVILBISS HEALTHCARE, LLC DV55D-HH NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Death