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

Model Number DSX500T11C

Device Problems Contamination (1120); Degraded (1153); Sparking (2595)

Patient Problems Dyspnea (1816); Epistaxis (4458)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The user alleged device is noisy, shoots out air, white stuff in the water chamber, burning odor coming from machine, sparked when plugged in, and difficulty breathing/short of breath.There was no report of serious patient harm or injury.The device with power accessories has not been returned for investigation.Labeling instructs the user to periodically inspect the ac power cord for signs of wear or damage and to replace the ac power cord if worn or damaged.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 previously received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged device is noisy, shoots out air, white stuff in the water chamber, burning odor coming from machine, sparked when plugged in, and difficulty breathing/short of breath.There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for investigation.During the investigation, observed the following from an external and internal inspection: found a light amount of brown dust around the blower inlet.Found very light dust-like contamination on top of the blower motor and the blower motor seal.Potential mineral deposit spots are on the top and bottom of the blower motor, in the blower motor, and on the bottom of the blower box, indicating potential water ingress.Black contamination, consistent with keratin, at the air outlet of the blower box.Not able to confirm the presence of degraded sound abatement foam.There is no visible damage or functionality failure on the device, which suggests that the source of contamination was external to the device.  the device's downloaded event log was reviewed by the manufacturer and found no errors.The manufacturer concludes not able to confirm the complaint or address the symptoms specified.In this report, section d9, g3, h3, h6 has been updated.

• 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: 14114054
• MDR Text Key: 298761975
• Report Number: 2518422-2022-13116
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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