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	Bronchitis (1752)
Date of Event	06/20/2024
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 patient states that her cpap machine does not seem to be producing as much air as it used to.Pink build up has been present in the water chamber for several years.Patient's health has been declining and now has bronchitis.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The patient did not allege foam or particles, and the bronchitis was assessed as a non-serious injury.There was no allegation of serious or permanent harm or injury.No medical intervention was required for the patient.Based on the information available at this time of investigation, it has been determined that there is no evidence that the device malfunctioned in a manner that would be likely to cause or contribute to death or serious injury if it were to recur.There was no serious patient harm or injury associated with this device and no increased risk to the intended user.Based on the information available, it is a non-reportable complaint.

• 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 15208 ; 4125423300
• MDR Report Key: 20193842
• Report Number: 2518422-2024-58215
• Device Sequence Number: 17862563
• Product Code: BZD
• UDI-Device Identifier: 00606959005464
• UDI-Public: 0100606959005464
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (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): 01/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2013
• 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
• 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
• Patient Sex: Unknown