FDA Adverse Event Death Summary report: N

DEVILBISS INTELLIPAP

MDR report key: 21677026 · Received March 24, 2025

Report

Report Number
MW5168016
Event Type
Death
Date Received
March 24, 2025
Date of Event
February 22, 2025
Report Date
March 17, 2025
Manufacturer
DEVILBISS HEALTHCARE LLC /3B MEDICAL INC.
Product Code
BZD
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND
Health Professional
*

Narratives

Description of Event or Problem · 0

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 1045 PM AND WOKE UP SOMETIME BETWEEN 5:30 AND 6 AM. 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 COMPLETELY OFF. THE MACHINE HAS NO EJECTION PORT, NO ALARM AND JUST SLIDES RIGHT OFF THE MACHINE. AT THE TIME I GOT TO MY MOTHER SHE COULD NOT CATCH HER BREATH AND DIED AT 6:42 AM. I TRIED REATTACHING BUT 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, SN (B)(6).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1718858 DEVILBISS INTELLIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD DEVILBISS HEALTHCARE LLC /3B MEDICAL INC.

Patients

Seq Age Sex Outcome Treatment
1 76 YR Female Death