MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTAR PRO C-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	AU461HS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Hepatic or Biliary Problem (4493)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted regarding the voluntary field safety notice/recall concerning the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient has been diagnosed with liver disease and believes the condition is related to the use of the device.The patient is seeking compensation and has indicated the intention to join a class action lawsuit if their request is not addressed.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This report is submitted to provide additional information from the manufacturer's final investigation findings and to include the product udi, related coding fields, and date received by mfg.The manufacturer previously reported: "the manufacturer was contacted regarding the voluntary field safety notice/recall concerning the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The patient has been diagnosed with liver disease and believes the condition is related to the use of the device.The patient is seeking compensation and has indicated the intention to join a class action lawsuit if their request is not addressed.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's 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: REMSTAR PRO C-FLEX
• 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: 21197136
• Report Number: 2518422-2025-100942
• Device Sequence Number: 7578496
• Product Code: BZD
• UDI-Device Identifier: 00606959005464
• UDI-Public: (01)00606959005464
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K113068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: AU461HS
• Device Catalogue Number: AU461HS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2015
• 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
• 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