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

Model Number DSX400T11

Device Problem Degraded (1153)

Patient Problems Asthma (1726); Headache (1880); Hypersensitivity/Allergic reaction (1907); Dizziness (2194); Respiratory Tract Infection (2420); Cough (4457); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Nodule (4551); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : the device has not yet been returned to the manufacturer.

Event Description

The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap/ bipap, and mechanical ventilator devices.The manufacturer received information alleging asthma (new or worsening) and reduced cardiopulmonary reserve, eye irritation, nose irritation, skin irritation, respiratory tract irritation, dizziness and/or headache, hypersensitivity, nodules in both lungs, sinus infections, postnasal drip, and constant cough.No other clinical information or medical interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION CPAP PRO
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: jenn canada ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19052715
• MDR Text Key: 339550640
• Report Number: 2518422-2024-17605
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial

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
• Device Model Number: DSX400T11
• Device Catalogue Number: DSX400T11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other