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

Model Number DSX500S11F

Device Problems Device Emits Odor (1425); Increase in Pressure (1491)

Patient Problems Chest Pain (1776); Dyspnea (1816); Unspecified Respiratory Problem (4464)

Event Date 10/15/2023

Event Type  malfunction  

Event Description

The manufacturer became aware that a user of the dreamstation auto cpap alleging chest pain, patient lungs feel sick, repeatedly resetting the device, yellow and dirty filters.Patient stated her device airflow pressure is too high that causes her difficulty in breathing during at night, that she needs to turn around while using the device because of the too much pressure.The pressure starts at 6.8 which is too high for the patient.The patient reported the air that comes out smells musty even if the patient changes the tubing.The patient also reported feeling drabby from not using the device and was not sleeping well without the device.The device was cleaned with dish washing detergent every after use.There was no report of serious patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

• 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 15208 ; 4125423300
• MDR Report Key: 18140957
• MDR Text Key: 328179066
• Report Number: 2518422-2023-30207
• 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
• Type of Report: Initial

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: DSX500S11F
• Device Catalogue Number: DSX500S11F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female