MAUDE Adverse Event Report: RESPIRONICS, INC. SYSTEM ONE HT HUMID ASSY; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DS6TFLG
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/17/2024
Type of Reportable Event	Death
Event or Problem Description
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 received information alleging an issue related to a cpap device's sound abatement foam.The patient has alleging kidney disease/toxicity, death, heart failure and lung failure.There was report of serious patient harm or injury.There was no medical intervention required by the patient.The device was returned to the manufacturer's product investigation laboratory for investigation.During investigation the manufacturer observed a black substance, consistent with sound abatement foam degradation, was observed on the outside bottom of the blower box and was stuck to it.Product investigation laboratory was able to confirm the presence of degraded sound abatement foam.Nine errors were logged.Dust like contamination at the air inlet, on the pca, in the blower box and throughout the inside enclosure.Product investigation laboratory can confirm the presence of multiple contaminants that are not consistent with degraded sound abatement foam from the secondary findings.Product investigation laboratory was unable to address the symptoms specified.The manufacturer used a fitt (foam integrity test tool) and was able to confirm the presence of degraded sound abatement foam.The device's event logs were downloaded and reviewed by manufacturer.The manufacturer found nine error codes.The manufacturer applied power to the device and verified airflow.The manufacturer concludes, there was evidence of sound abatement foam degradation/breakdown and observed multiple contaminants and was not able to confirm the complaint or address the symptoms specified.
Additional Manufacturer Narrative
In this report box c: single-use device? (rfb) has been corrected.

• Brand Name: SYSTEM ONE HT HUMID ASSY
• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 23402599
• Report Number: 2518422-2025-050056
• Device Sequence Number: 13229496
• Product Code: BZD
• UDI-Device Identifier: 00606959032132
• UDI-Public: (01)00606959032132
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: DS6TFLG
• Device Catalogue Number: DS6TFLG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2013
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown