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

Model Number DSX500H11

Device Problem Use of Device Problem (1670)

Patient Problems Headache (1880); Liver Damage/Dysfunction (1954); Unspecified Respiratory Problem (4464); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Began using a philips cpap machine in 2014.Diagnosed with liver damage and liver disease after using the machine.Suffers from chronic respiratory issues and headaches - attributed to use of cpap machine.

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 17218524
• MDR Text Key: 318138503
• Report Number: MW5118880
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500H11
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BLOOD PRESSURE MEDICATION.; CHOLESTEROL MEDICATION.; METFORMIN.
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male