MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR SYSTEM ONE 60 SERIES; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU461S
Medical Device Problem Codes	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Cancer (3262)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
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 that the remstar pro c-flex+ device had caused the development of lung cancer.Lymph nodes were biopsied and awaiting results.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This report is being submitted to correct the adverse event/product problem, b5, and type of reported complaint sections to reflect the non-serious injury alleged and to update the (device) problem code grid, patient outcome code grid, health impact grid, component code grid, and to include the product unique device identification (udi).
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 that the remstar pro c-flex+ device had caused non-serious injuries.The patient reports, ¿4 spots located on her lungs.Biopsy completed on lymph nodes, pending results.Biopsy to be done on lungs in future, lungs (spots) too small to compete a biopsy on at this time.She recently was feeling extremely tired.¿ additional information was requested.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was previously 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 that the remstar pro c-flex+ device had caused non-serious injuries.The patient reports, ¿4 spots located on her lungs.Biopsy completed on lymph nodes, pending results.Biopsy to be done on lungs in future, lungs (spots) too small to compete a biopsy on at this time.She recently was feeling extremely tired.¿ additional information was requested.Despite multiple good-faith efforts the device has not been returned to manufacturer.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.Section g3 and h6 updated/corrected.

• Brand Name: REMSTAR SYSTEM ONE 60 SERIES
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 20727183
• Report Number: 2518422-2024-104250
• Device Sequence Number: 8370851
• Product Code: BZD
• UDI-Device Identifier: 00606959005440
• UDI-Public: (01)00606959005440
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: AU461S
• Device Catalogue Number: AU461S
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: Not provided; 03/18/2026
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 03/04/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2016
• 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: Life Threatening
• Patient Age: 76 YR
• Patient Sex: Female