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

Model Number CAX501H12C

Device Problem Degraded (1153)

Patient Problems Headache (1880); Nausea (1970); Pneumonia (2011); Dizziness (2194); Sore Throat (2396); Cancer (3262); Wheezing (4463); Unspecified Respiratory Problem (4464)

Event Date 11/03/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The manufacturer was contacted about 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 a lung cancer diagnosis along with pneumonia.The patient also alleges nasal and throat irritation, mucus, difficulty breathing, heavy wheezing, nausea, lightheadedness, dizziness, and headaches.The doctors found black particles in the patient's lungs.The patient is alleging black particles in the machine.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: DREAMSTATION EXPERT
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18166472
• MDR Text Key: 328477528
• Report Number: 2518422-2023-31036
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 11/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CAX501H12C
• Device Catalogue Number: CAX501H12C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2019
• 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): Life Threatening