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

Model Number DSX200H11

Device Problems Degraded (1153); Device Contamination with Chemical or Other Material (2944)

Patient Problems Sore Throat (2396); Respiratory Tract Infection (2420); Unspecified Respiratory Problem (4464)

Event Date 09/14/2021

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The manufacturer received information alleging particles in the device and a grey ring.The patient has respiratory issues and sore throat and sinus infection.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 an issue related to continuous positive airway pressure (cpap) device's sound abatement foam.There was no report of patient harm or injury.The patient also alleged particles in the device and a grey ring.The patient has respiratory issues, sore throat and sinus infection.The device was returned to the manufacturer's quality product investigation laboratory for investigation.The manufacturer visually inspected the device.Evidence of water ingress on the blower and blower box was found.Pca screw hole on the blower box cracked and came loose while disassembling.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout the device enclosure and air path suggesting a source external to the device.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found no error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes there was no evidence of sound abatement foam degradation in the base unit but presence of contamination in the air path was confirmed.Dust/dirt contamination inconsistent with degraded sound abatement foam was observed throughout the device enclosure and air path.Section d5 (operator of device) was missed in the initial report, which was correctly updated in this follow up report.Section h6 was 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: 13518924
• MDR Text Key: 293147246
• Report Number: 2518422-2022-04078
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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