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

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Asthma (1726); Conjunctivitis (1784); Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

I have had recurring conjunctivitis, device-induced asthma, sinus and upper respiratory infections, cough, and numerous sicknesses caused by the philips dreamstation autolevel bipap.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION AUTOLEVEL BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12835609
• MDR Text Key: 281027710
• Report Number: MW5105427
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 11/17/2021
• Patient Sequence Number: 1
• Treatment: CYMBALTA ; OMEPRAZOLE ; TOPRIL XL ; XANAX; ZOLOFT
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 218 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White