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

Model Number DSX520T11C

Device Problem Decrease in Pressure (1490)

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Pleural Effusion (2010); Pulmonary Edema (2020)

Event Date 08/15/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging a dreamstation 2 advanced auto cpap contributed to hospitalization of a user.The user was hospitalized (b)(6) 2022, for atrial fibrillation which was treated with cardioversion.Cardioversion was also performed on (b)(6) 2022.The user also alleges shortness of breath, bilateral pleural effusions, and pulmonary edema.There was no report of serious patient harm or injury.Upon further investigation, the manufacturer became aware of the end user changing prescribed settings and using his wife's device instead of his own.The manufacturer discouraged this and gave recommendations to ensure proper use of device.The manufacturer's investigation is ongoing.A final report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.Additional information was received and section b5 should be reported as: 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 atrial fibrillation which was treated with cardioversion,shortness of breath, bilateral pleural effusions, and pulmonary edema.There was no medical intervention required by the patient.The reported event of  atrial fibrillation which was treated with cardioversion,shortness of breath, bilateral pleural effusions, and pulmonary edema and its reported severity was reviewed by the manufacture's clinical expert.This event is assessed as not related to the device in this case.Based on the available information,the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.The device has not yet returned to the manufacturer for evaluation.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Section(s) b1, b2, has changed related to the complaint changing from the reported adverse event to a product problem.Section h1 has changed to reflect a malfunction.Section h9 has been updated in this report. section h6 health effect- impact code, type of investigation findings and investigation conclusions has been updated.

• 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 15206 ; 2673970028
• MDR Report Key: 15392036
• MDR Text Key: 299578170
• Report Number: 2518422-2022-80327
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male