MAUDE Adverse Event Report: RESPIRONICS, INC. REMSTARPROCFLEX+; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	CA461TBT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Sore Throat (2396); Unspecified Respiratory Problem (4464); Voice alteration (4906)
Date of Event	05/26/2023
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 an issue related to a cpap device's sound abatement foam.The patient has alleged to experiencing nasal/throat irritation and soreness and loss of voice.There was no report of serious patient harm or injury.There was no medical intervention 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
As per device evaluation received on 08/18/2025: the device "remstarprocflex+" was returned to the third party service center for evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and visible foam particles were not observed.In addition, dust was found in contamination findings.Additionally, the patient¿s complaint was not confirmed, and the device was scrapped.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In this report, box d, h has been updated/corrected.

• Brand Name: REMSTARPROCFLEX+
• 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 ; 7247330200
• MDR Report Key: 17060949
• Report Number: 2518422-2023-12828
• Device Sequence Number: 8783789
• Product Code: BZD
• UDI-Device Identifier: 00606959030190
• UDI-Public: (01)00606959030190
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: CA461TBT
• Device Catalogue Number: CA461TBT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2015
• 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
• 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