MAUDE Adverse Event Report: PHILLIPS RESPIRONICS / RESPIRONICS, INC. DREAMSTATION AUTO CPAP WITH HUM DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Sore Throat (2396); Cough (4457)

Event Date 09/07/2020

Event Type  Injury  

Event Description

Started having headaches, throat irritation, and coughing in the mornings after using my cpap machine (dreamstation) made by phillips respironics.Did not go to the doctor as covid restrictions were in place and it was difficult to get appointments.Also i was able to manage the symptoms on my own.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP WITH HUM DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 12136405
• MDR Text Key: 260721986
• Report Number: MW5102356
• Device Sequence Number: 1
• Product Code: BZD
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 100