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	12/29/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer became aware of an allegation of bipap autosv adv.The manufacturer received information stating that the patient has passed away.There is no allegation of serious or permanent harm or injury.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 manufacturer became aware of an allegation of bipap autosv adv.The manufacturer received information stating that the patient has passed away.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to the third-party service centre for further evaluation.During the evaluation of the device at the third-party service centre, the device was visually inspected and found no evidence of visible foam particles.The technician confirmed no particles in the air path.During the evaluation, secondary findings was observed.There was no error code found.The third-party service centre concludes that they couldn't confirm the customer's allegation and unit scrapped.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.Box h: evaluation method code, evaluation results code, component code grid and conclusion code grid has been updated.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 21052373
• Report Number: 2518422-2025-000037
• Device Sequence Number: 8023273
• Product Code: MNS
• UDI-Device Identifier: 00606959029798
• UDI-Public: (01)00606959029798
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• 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
• Report Date (Section B): 07/23/2025

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: DS960XHS
• Device Catalogue Number: DS960XHS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2016
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown