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

Model Number	DSXH
Medical Device Problem Codes	Contamination (1120); Degraded (1153)
Health Effect - Clinical Codes	Dyspnea (1816); Cough (4457); Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The device was returned and observe continue level error, particle contamination on bottom enclosure, top enclosure, and on rear panel during device evaluation.There was no allegation of harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res 88058.
Additional Manufacturer Narrative
This mdr is being submitted as part of a batch submission of complaints that were reassessed as reportable foam degradation complaints; discovered as part of a retrospective remediation review.
Additional Manufacturer Narrative
The manufacturer received information alleging an issue related to a device's sound abatement foam.There was no report of patient harm or injury.A correction to b5 was made and should be: 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 visualization of particles, nasal irritation, constant coughing and shortness of breath related to a cpap device's sound abatement foam.There was no report of serious patient harm or injury.The device was returned to the manufacturer's product investigation laboratory for further evaluation.The device was evaluated.Adhesive residue observed on top of the flip lid.The internal investigation began with inspecting the water tank.Indeterminate white crystalline flakes were observed all over the inside bottom of the water tank.Similar contaminants were observed on the heater plate.An indeterminate brown contaminant, likely biocontamination, was observed inside the bottom enclosure and on the lifting tray.The flip lid seal was found to be intact but covered with white and black dust-like contamination.The dry box assembly was removed by removing the back panel.Blonde hair-like objects and white dust-like contaminants were found between the back panel and dry box assembly.The device's downloaded logs were reviewed by manufacturer.There were no errors found.The manufacturer concludes that they could not confirm the customer allegation.It was able to confirm the presence of various indeterminant contaminants and hair-like objects in the water tank, which are likely of external origin and not consistent with originating from a device failure.Also, unable to find any signs of degraded sound abatement foam that could have been emanated from the user's base unit into the humidifier received.

• Brand Name: DREAMSTATION HUMIDIFIER
• Common Device Name: 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: 13957229
• Report Number: 2518422-2022-06830
• Device Sequence Number: 14497243
• Product Code: BZD
• UDI-Device Identifier: 00606959022645
• UDI-Public: 00606959022645
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: DSXH
• Device Catalogue Number: DSXH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown