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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Vertigo (2134); Dizziness (2194); Respiratory Tract Infection (2420)

Event Date 09/01/2017

Event Type  Injury  

Event Description

Repetitive severe lung infections, upper respiratory infections, sinus infections, ear infections, dizziness, vertigo, hospitalization, prednisone in high doses and intravenous antibiotics, solumedrol shots.After continually having issues i switched back to my old bipap machine.There are multiple walk in clinic, hospitalizations and dr visits.Fda safety report id # (b)(4).

• Brand Name: BIPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 12787459
• MDR Text Key: 280746405
• Report Number: MW5105236
• 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: 11/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White