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

Model Number DSX500T11C

Device Problem Degraded (1153)

Patient Problems Dyspnea (1816); Headache (1880); Sore Throat (2396); Respiratory Tract Infection (2420); Epistaxis (4458); Respiratory Insufficiency (4462); Dry Mouth (4485); Localized Skin Lesion (4542)

Event Date 01/31/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging particles in tubing/changer related to the cpap device's sound abatement foam.User also reported experiencing blood, mucus, scabs coming from nose; dry mouth; sores in mouth, on tongue and lips; difficulty breathing and shortness of breath; nasal/throat irritation or soreness; headache.User also reported burning/smoke/electrical odor.There was no allegation of serious or permanent harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.

Manufacturer Narrative

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 device.The manufacturer previously received information alleging particles in tubing/chamger related to the cpap device's sound abatement foam.User also reported experiencing blood, mucus, scabs coming from nose; dry mouth; sores in mouth, on tongue and lips; difficulty breathing and shortness of breath; nasal/throat irritation or soreness; headache and nose bleeds.User also reported burning/smoke/electrical odor.There was no allegation of serious or permanent harm or injury.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 h6 was updated in this report.

• 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: 13656393
• MDR Text Key: 286858185
• Report Number: 2518422-2022-07530
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Device Catalogue Number: DSX500T11C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 03/02/2022
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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