MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION 2 ADV AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX520T11C

Device Problems Use of Incorrect Control/Treatment Settings (1126); Noise, Audible (3273)

Patient Problems Angina (1710); Bradycardia (1751); Dyspnea (1816); Vomiting (2144); Confusion/ Disorientation (2553); Cough (4457)

Event Date 07/01/2022

Event Type  Injury  

Event Description

The manufacturer received information alleging a dreamstation 2 advanced auto cpap caused an end user to feel sick after using the device in july of 2022.The user alleges the device grinds and is loud.The user alleges she went to the doctor and found out there was somebody else's chip in the device and the device had scratches on it.The user alleges after a while of using the device her brain is not functioning right, she can't think straight, she is experiencing bradycardia, chest tightness, shortness of breath, a cough, and she vomited a lot of times.The user reportedly saw a pulmonologist and was prescribed cough medicine.The user alleges she still has a cough, but not as much after her new chip was inserted.The device was not replaced.A representative of the manufacturer went over how prescriptions are put into the device by the dme.The user wore the device and it appeared to be working properly.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

Manufacturer Narrative

H3 other text : device not returned to the manufacturer.

• Brand Name: DREAMSTATION 2 ADV 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17060267
• MDR Text Key: 316573417
• Report Number: 2518422-2023-12862
• 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: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: DSX520T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/07/2022
• 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: 74 YR
• Patient Sex: Female