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

Model Number DSX200H11C

Device Problems Contamination (1120); Degraded (1153)

Patient Problems Stroke/CVA (1770); Dyspnea (1816); Headache (1880); Sore Throat (2396); Respiratory Tract Infection (2420); Taste Disorder (4422)

Event Date 09/27/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged of having nasal/throat irritation, soreness, difficult to breath/shortness of breath and headache.Patient also alleged of having stroke and lost her sense of smell.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged of having nasal/throat irritation, soreness, difficult to breath/shortness of breath and headache.Patient also alleged of having stroke and lost her sense of smell.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the internal and external part of the device and found a hair-like particle on the top enclosure.An unknown dust contaminant was observed on the blower seal.During the investigation of the humidifier, an observation was made of an unknown black contaminant on the water tank.An unknown dust contaminant was observed on the bottom enclosure.The device was missing one of the back panel screws.A hair-like particle was observed on the heater plate cable.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer used a known good power supply and power cord to confirm the device powered up, provided airflow, a known good heated tube heats, and the heater plate heats.The manufacturer concludes there was no evidence of sound abatement foam degradation/breakdown was observed in this device.Section h6 were 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: 14935504
• MDR Text Key: 295362642
• Report Number: 2518422-2022-58182
• 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: 10/27/2023

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: DSX200H11C
• Device Catalogue Number: DSX200H11C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 07/06/2022
• Supplement Dates Manufacturer Received: 10/07/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2021
• 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