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

Model Number DSX200H11

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Ulcer (2274); Heart Failure/Congestive Heart Failure (4446); Epistaxis (4458); Unspecified Eye / Vision Problem (4471); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged of having difficulty breathing/short of breath, congestive heart failure, major heart surgery, sores in nose and bleeding a lot.The patient also alleged of having headaches and little veins in her eyes bleeding.The manufacturer's investigation is ongoing.A follow-up 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 soundabatement 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 alleged to experience congestive heart failure (ejection fraction is going down), major heart surgery, nose sores and bleeding a lot, severe headches, litle veins in eyes bleeding, difficulty breathing/shot of breath.The patient received medical intervention.The reported events of congestive heart failure (ejection fraction is going down), major heart surgery, nose sores and bleeding a lot, severe headches, litle veins in eyes bleeding, difficulty breathing/shot of breath and its reported severity was reviewed by the manufacture's clinical expert.These events were assessed as not related to the device in this case.Based on the available information, the manufacture concludes no further action is necessary.The device has not yet returned to the manufacturer for evaluation and at this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.Sections 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 h6 health effect - clinical code was corrected, health effect- impact code, type of investigation, investigation findings and investigation conclusions has been updated.

• Brand Name: DREAMSTATION 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: 15000224
• MDR Text Key: 295782470
• Report Number: 2518422-2022-59443
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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: DSX200H11
• Device Catalogue Number: DSX200H11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• 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): Other