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

Device Problem Particulates (1451)

Patient Problems Asthma (1726); Dyspnea (1816); Headache (1880); Respiratory Tract Infection (2420); Cough (4457); Skin Inflammation/ Irritation (4545)

Event Date 06/26/2021

Event Type  Injury  

Event Description

Began using dreamstation cpap continuous positive airway pressure in 2018.Noticed black particles in tubing: sinus issues, headaches; respiratory infections, irritated eyes and skin; coughing, trouble breathing, worsened asthma.

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17217831
• MDR Text Key: 318115987
• Report Number: MW5118871
• 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
• Patient Outcome(s): Hospitalization; Disability; Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 121 KG
• Patient Race: White