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

Model Number DSX200H11

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Convulsion/Seizure (4406); Swelling/ Edema (4577)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a continuous positive airway pressure (cpap) device's sound abatement foam.The patient alleges seizure, shortness of breath, and tongue swelling.Patient also alleges that the device has a strange odor.Medical intervention was not specified.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 information 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 patient alleged seizure, shortness of breath, losing weight, and tongue swelling.Patient also alleges that the device has a strange odor.Additional information has been received after review from a clinical expert that the allegation of seizures and losing weight was assessed as not related to the device and therefore is not a reportable injury.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.This report is being filed as a correction to the original report and is no longer an adverse event.This is being filed as a product problem only.The previous report was also filed as an initial/final, however the manufacturer's investigation is now ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.The updated coding in h6 reflects this change.

• 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 ; 7249003460
• MDR Report Key: 13871636
• MDR Text Key: 288050004
• Report Number: 2518422-2022-11728
• 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: 04/26/2023

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
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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