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

Model Number DSG500S11

Device Problem Degraded (1153)

Patient Problems Fatigue (1849); Neuropathy (1983); Blurred Vision (2137); Numbness (2415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/04/2021

Event Type  Injury  

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 an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleged to shortness of breath, headaches, chest pressure, burning eyes and brain fog, upper airway irritation, experiencing nerve abnormalities where he has tingling in different parts of his body, waking up more tired, blurred vision, eyes were weepy and numbness.The reported events of shortness of breath, headaches, chest pressure, burning eyes and brain fog, upper airway irritation, experiencing nerve abnormalities where he has tingling in different parts of his body, waking up more tired, blurred vision, eyes were weepy, numbness and its reported severity was reviewed by the manufacture's clinical expert.These events are assessed as related to the device in this case.Based on the available information, the manufacturer concludes no further action is necessary.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this follow-up report will be filed.

• Brand Name: DREAMSTATION GO AUTO
• 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 15206 ; 2673970028
• MDR Report Key: 18100379
• MDR Text Key: 327716255
• Report Number: 2518422-2022-04483
• 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
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSG500S11
• Device Catalogue Number: DSG500S11
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1974-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male