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 Respiratory Problem (4464)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged reduced lung function while using the device.Medical intervention was not specified.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Additional information was received on jan 19, 2023, and section h11 should be reported as: the manufacturer received information alleging an issue related to a cpap device's sound abatement foam.Patient alleged of having nasal/throat irritation or soreness and blood cancer.The sections b1, b2, h1, h6 have been corrected in this report as follows: section b1 was corrected to product problem (adverse event and product problem was checked in the previous mdr) section h1 was changed from serious injury.To malfunction.Section h6 health effects - impact code was corrected.
Additional Manufacturer Narrative
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.The manufacturer has updated h6 in this report.

• Brand Name: REMSTAR PRO C-FLEX
• 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 15206 ; 7243512041
• MDR Report Key: 14733066
• Report Number: 2518422-2022-43302
• Device Sequence Number: 2276271
• Product Code: BZD
• UDI-Device Identifier: 00606959005464
• UDI-Public: 00606959005464
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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: 06/16/2022
• Supplement Date Received by Manufacturer: 12/04/2024; 11/25/2025
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 12/14/2024; 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2012
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 88058
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female