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

Model Number	AU461S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Dizziness (2194); Low Oxygen Saturation (2477); Skin Inflammation/ Irritation (4545)
Date of Event	01/07/2022
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 low oxygen levels, dizziness, and serious skin eruptions that are breaking out constantly 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
The manufacturer previously received information alleging an issue related to a cpap device's sound abatement foam.The patient alleged low oxygen levels, dizziness, and serious skin eruptions that are breaking out constantly while using the device.Medical intervention was not specified.The device has not yet been returned to the manufacturer for evaluation.Three attempts to have the device returned for evaluation and investigation were unsuccessful.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In the initial report, the manufacturer submitted the allegation as both an adverse event and a product problem.Upon further review, it has been determined that the patient's report of low oxygen levels, dizziness, and serious skin eruptions that are breaking out constantly while using the device should have been reported as a product problem only.The review concluded that the event does not meet the criteria for a serious injury as defined in 21 cfr 803.3.The manufacturer has updated b1, adverse event or product problem to product problem only in this report.In the previous report, both were selected.The manufacturer has updated b2, outcomes attributed to adverse event to blank in this report.In the previous report, other serious or important medical events was selected for b2.The manufacturer has updated h1, type of reportable event, to malfunction in this report.In the previous report, serious injury was selected.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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7243512041
• MDR Report Key: 14360630
• Report Number: 2518422-2022-19952
• Device Sequence Number: 17360029
• Product Code: BZD
• UDI-Device Identifier: 00606959005440
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: AU461S
• Device Catalogue Number: AU461S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2013
• 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: Male