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

Model Number DNX500H11C

Device Problem Degraded (1153)

Patient Problems Pulmonary Embolism (1498); Asthma (1726); Dyspnea (1816); Fatigue (1849); Headache (1880); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/06/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a cpap device's sound abatement foam became degraded and caused the patient to be diagnosed with deep vein thrombosis (dvt)and a pulmonary embolism.The patient did receive medical intervention in the form of a ct scan while hospitalized.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

The manufacturer previously reported an allegation of an issue related to sound abatement foam.A correction to b5 was made and should be: 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 previously reported an allegation of an issue related to sound abatement foam that became degraded and caused the patient to have deep vein thrombosis (dvt)and a pulmonary embolism, short of breath, headaches, asthma, fatigue and chest pressure.The patient did receive medical intervention in the form of a ct scan while hospitalized.Based on the available information, the manufacture concludes no further action is necessary.There was no medical intervention required by the patient.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting an updated report at this time.If pertinent information becomes available to the manufacturer at a later date, a follow-up report will be filed.  section d4, h4, and section h6 health effect- clinical code, type of investigation, investigation findings and investigation conclusions have been updated in this report.

• 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: 12791291
• MDR Text Key: 280684851
• Report Number: 2518422-2021-06587
• 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
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DNX500H11C
• Device Catalogue Number: DNX500H11C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2019
• 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; Required Intervention; Hospitalization
• Patient Sex: Female