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

Model Number DSX500T11C

Device Problem Insufficient Information (3190)

Patient Problem Stroke/CVA (1770)

Event Date 01/09/2022

Event Type  Injury  

Event Description

The manufacturer became aware that a user whose machine was discarded in (b)(6) 2021, had a stroke in (b)(6) 2022.The user is alleging his stroke and subsequent hospitalization was due to not having a replacement device to use for his sleep apnea.The user is now home receiving physical and speech therapy.No device is returning for investigation.The philips respironics dreamstation systems deliver positive airway pressure therapy for the treatment of obstructive sleep apnea in spontaneously breathing patients weighing over (b)(6).It is for use in the home or hospital/institutional environment.This device is not intended for life support.Device was previously reported on 2518422-2022-00767.The manufacturer concludes that we are unable to confirm the user's allegations due to the device not returning.We will be submitting this report as an initial final report.If additional information is obtained, we will submit a follow up report.No further action is necessary at this time.

• Brand Name: DREAMSTATION 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: 13543846
• MDR Text Key: 285755032
• Report Number: 2518422-2022-04684
• 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
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HUMIDIFIER NO SN
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male