MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP SYNCHRONY AVAPS; VENTILATOR, CONTINUOUS NON-LIFE-SUPPORTING

Model Number	1169P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In the box b: b5 verbiage was wrongly captured in the previous report and corrected in this report.A device was returned to a manufacturer's service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the manufacturer's service center, the device was visually inspected and found evidence of foam degradation.During the evaluation, the device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer's service center.There was 1024 error codes found.The manufacturer's service center concludes that there were visible foam degradation and unit got scrapped.In box h: evaluation results code, component code and conclusion code was corrected in this report.
Event or Problem Description
The device was returned to a manufacturer service center in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.During the evaluation of the device at the manufacturer service center, the device was visually inspection found no evidence of foam degradation.During the evaluation, the device powered on and airflow was confirmed.The device's downloaded logs were reviewed by the manufacturer service center.There was 1024 error code found.The manufacturer service center concludes that there were no visible foam degradation and unit got scrapped.
Additional Manufacturer Narrative
This report is being submitted as part of a batch submission of complaints deemed reportable following record correction and remediation efforts.

• Brand Name: BIPAP SYNCHRONY AVAPS
• Common Device Name: VENTILATOR, CONTINUOUS NON-LIFE-SUPPORTING
• 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: 23670744
• Report Number: 2518422-2025-058655
• Device Sequence Number: 13232089
• Product Code: MNS
• UDI-Device Identifier: 00606959045231
• UDI-Public: (01)00606959045231
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K102465
• 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): 12/05/2025

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: Other
• Device Model Number: 1169P
• Device Catalogue Number: 1169P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2018
• 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-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown