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

Model Number DSX500T11C

Device Problem Degraded (1153)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Headache (1880); Hemoptysis (1887); Nausea (1970); Sneezing (2251); Sore Throat (2396); Low Oxygen Saturation (2477); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam and alleged visualization of black particles.Patient also alleged sore throat, sneezing after putting on the mask, runny nose, cough, nausea, headaches, lack of oxygen, trouble in breathing.There was no report of serious or permanent patient 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 devices.The manufacturer received information alleging an issue related to a cpap device's sound abatement foam and alleged visualization of black particles.Patient also alleged sore throat, sneezing after putting on the mask, runny nose, cough, nausea, headaches, lack of oxygen, trouble in breathing.There was no report of serious or permanent patient harm or injury.Additional information received and section b5 should be updated as: 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 received information alleging an issue related to a cpap device's sound abatement foam and alleged visualization of black particles.Patient also alleged sore throat, sneezing after putting on the mask, runny nose, cough, nausea, headaches, lack of oxygen, trouble in breathing.The patient also alleged seing the black silvers foam and having stomach pain, spot of blood in mucus, coughing up foam.There was no report of serious or permanent patient 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 updated in this report.Section e1 has been 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: 15175744
• MDR Text Key: 298991883
• Report Number: 2518422-2022-04366
• 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: 08/30/2023

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
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2017
• 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