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

Model Number	DS960XHS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
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 manufacturer received information alleging visualization of particles.There was no report of medical intervention.The device has not been returned to the manufacturer.At this time, no further investigation can be requested.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
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 visualization of particles.There was no report of medical intervention.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and 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 third-party service center.There was three error codes found.The third-party service center concludes that they couldn't confirm the customer's allegation and there were no visible foam degradation and unit got scrapped.In this report, in box h method code, results code and conclusion code has been updated/corrected.
Additional Manufacturer Narrative
This mdr was previously reported under mfr 2518422-2024-106008 and is therefore a duplicate.

• Brand Name: BIPAP AUTOSV ADV
• 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: 21264868
• Report Number: 2518422-2025-009255
• Device Sequence Number: 9475605
• Product Code: MNS
• UDI-Device Identifier: 00606959029798
• UDI-Public: (01)00606959029798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2026

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: DS960XHS
• Device Catalogue Number: DS960XHS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 05/18/2025; 01/13/2026
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 10/10/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2015
• 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-1973-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown