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

Model Number	IN6H
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported serious injury of cancer (lung carcinoma) and damage to lung tissue occurred in relation to the device.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 serious injury of cancer and lung damage.Medical intervention was not specified.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported "the customer reported serious injury of cancer (lung carcinoma) and damage to lung tissue occurred in relation to the device.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 serious injury of cancer and lung damage.Medical intervention was not specified.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.".The product associated with this complaint was not returned to the manufacturer.This report is being sent to conclude that no further investigation is possible.No device has been returned.No further evaluation is possible at this time.Multiple attempts to have the device returned for evaluation and investigation were unsuccessful.In addition, capa pr 7211 documents the investigation into similar complaints, correction/removal activities have been initiated (refer to h.9), and complaint code trending is reviewed on a periodic basis to evaluate field quality performance, and as an input to risk management activities.

• Brand Name: SYSTEM ONE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20295096
• Report Number: 2518422-2024-100957
• Device Sequence Number: 8086209
• Product Code: BZD
• UDI-Device Identifier: 00606959014244
• UDI-Public: (01)00606959014244
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: IN6H
• Device Catalogue Number: IN6H
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• 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