MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS DREAMSTATION BIPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Device Problem Device Emits Odor (1425)

Patient Problems Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/15/2020

Event Type  Injury  

Event Description

I use a philips dreamstation bipap machine for obstructive sleep apnea and from (b)(6) 2020 forward have consistently had problems with the machine.It seems like the humidifier plate is burning, as the machine often gives off a burning plastic smell.I've had chronic upper respiratory and sinus problems since that date and occasionally wake up sick to my stomach following overnight usage.I replaced the machine with a new model of the same machine in early 2021 and have continued to experience symptoms.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION BIPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12202811
• MDR Text Key: 262929412
• Report Number: MW5102655
• Device Sequence Number: 1
• Product Code: MNS
• 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: 07/17/2021

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: 07/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 37 YR
• Patient Weight: 54