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

Model Number DSX500S11

Device Problem Degraded (1153)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Stroke/CVA (1770); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2022

Event Type  malfunction  

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 cpap device's sound abatement foam.The patient has alleged stroke,cardiac arrest,afib.There was no medical intervention required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The following correction has been updated in this report.Section "both" in box b has been updated/corrected to reflect product problem and also b7 section has been updated.Section "type of reported complaint" in box h has been updated/corrected to reflect product problem.Section h6 health effect- impact code has and patient outcome code grid has been updated.

• 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 15208 ; 4125423300
• MDR Report Key: 15905691
• MDR Text Key: 304706419
• Report Number: 2518422-2022-100932
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11
• Device Catalogue Number: DSX500S11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Removal/Correction Number: RES 88058
• Patient Sequence Number: 1
• Patient Outcome(s): Other