MAUDE Adverse Event Report: UNKNOWN BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Device Emits Odor (1425); Improper Flow or Infusion (2954)

Patient Problems Aspiration/Inhalation (1725); Headache (1880); Nausea (1970); Choking (2464); Cough (4457)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Dreams station humidifier runs out of water choking me with burning fumes.On low #4 setting with full distilled water setting it burns up after 6 hrs of sleep.I'm awaken coughing, headache & nauseous.This is my 3rd bipap.They require an "auto shutoff".Please contact me.I believe i have a court case against respironics.I have read numerous complaints about this issue but respironics continues to state it's the patience fault.

• Brand Name: BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16254125
• MDR Text Key: 308422586
• Report Number: MW5114537
• Device Sequence Number: 2
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/25/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: SYNTHROID, LISINOPRIL.; VIT C, D, OMEGA 3.
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White