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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Atrial Fibrillation (1729); Bronchitis (1752); Headache (1880); Chronic Obstructive Pulmonary Disease (COPD) (2237); Respiratory Tract Infection (2420); Respiratory Insufficiency (4462)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Began using dreamstation cpap in 2019; sinus issues, copd(chronic obstructive pulmonary disease) in 2020.Bronchitis, shortness of breath, headaches, respiratory tract infection, atrial fibrillation.

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17217548
• MDR Text Key: 318100586
• Report Number: MW5118864
• 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: 06/22/2023

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
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BLOOD THINNER; METATROPHIL
• Patient Outcome(s): Other; Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Sex: Male