MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION2ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520H11C

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Dyspnea (1816); Unspecified Respiratory Problem (4464)

Event Date 04/14/2023

Event Type  Injury  

Manufacturer Narrative

Device has not been returned to the manufacturer.

Event Description

The manufacturer became aware that a user of a dreamstation2 auto cpap device alleges his machine is covered with a white, powdery substance that is also on the inlet filter.The user received replacement filters, but the problem continues to be an issue.The user also alleges his air pressure changes and he is having difficulty breathing.The doctor for the user states the user has patches on his lungs from using his device.The va replaced the unit for the patient.The device has not yet been returned to the manufacturer.The investigation is ongoing.When the investigation is complete, a follow up final will be filed.

• Brand Name: DREAMSTATION2ADV AUTO CPAP
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17208261
• MDR Text Key: 317912984
• Report Number: 2518422-2023-14280
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200480
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: DSX520H11C
• Device Catalogue Number: DSX520H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male