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

Model Number	DS6TFLG
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Asthma (1726); Dry Eye(s) (1814); Hypersensitivity/Allergic reaction (1907); Dizziness (2194); Chronic Obstructive Pulmonary Disease (COPD) (2237); Unspecified Heart Problem (4454); Unspecified Respiratory Problem (4464); Skin Inflammation/ Irritation (4545); Eye Irritation (4803)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
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 eye irritation, skin irritation, dizziness and/or headache, hypersensitivity, nausea / vomiting, asthma (new or worsening) lung disease, other,copd- dry eye drops , irrigular heart beat.No other clinical information or medical interventions were reported.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional 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 received information alleging eye irritation, skin irritation, dizziness and/or headache, hypersensitivity, nausea / vomiting, asthma (new or worsening) lung disease, other,copd- dry eye drops , irregular heart beat.No other clinical information or medical interventions were reported.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.In box g: date received by mfg (rfb) has been updated.In box h: component code grid has been updated.

• Brand Name: SYSTEM ONE HT HUMID ASSY, DOM
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19918752
• Report Number: 2518422-2024-49269
• Device Sequence Number: 15479737
• Product Code: BZD
• UDI-Device Identifier: 00606959032132
• UDI-Public: (01)00606959032132
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2015
• 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: Other
• Patient Sex: Unknown