MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Particulates (1451); Output Problem (3005)

Patient Problems Dyspnea (1816); Headache (1880); Sneezing (2251); Irritability (2421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/01/2018

Event Type  malfunction  

Event Description

Started noticing trouble breathing with exertion and frequently nose running and sneezing when using machine at night.Headaches upon waking up.Machine seemed to be getting louder each month.Had to change filters frequently because of black color thought noise was from restricted filter.Was treated for throat irritation with medication.Sonogram of liver showed growths.Had thyroid removed because of growths.When switched to a replacement symptoms related to breathing diminished.Fda safety report id# (b)(4).

• Brand Name: BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 12829576
• MDR Text Key: 280961581
• Report Number: MW5105386
• Device Sequence Number: 1
• 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: 11/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2021
• Patient Sequence Number: 1
• Treatment: ASA 81MG; B12; CRESTOR ; LOSARTAN ; METFORMIN ; MULTI MALE 50+; SYNTHROID; TRULICITY
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White