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

Model Number	960P
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
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 that the patient alleging lung disease.There was no report of medical intervention.The device was returned to the manufacturer's service center for further evaluation.During the investigation the manufacturer observed unknown and dust-like contamination on the top enclosure/ui panel, left and right-side panels, and several spots on the bottom enclosure.2 additional labels were observed on the bottom enclosure due to the serial label not being completely legible.The manufacturer observed fingerprints on the bottom of the motor blower (most likely from assembly).A small piece of debris was observed in the bottom enclosure.Evidence of sound abatement foam degradation/breakdown was not observed.The manufacturer observed an unknown and dust-like contamination on the flip lid assembly and left side panel.The manufacturer observed dried liquid on the top and sides of the water chamber.The manufacturer observed dust-like contamination and potential hair-like particles in the humidifier bottom enclosure, on the dry box, heater plate, and in the lower base.The manufacturer observed a brownish dust-like contamination on the flip lid seal and dry box outlet seal.Evidence of sound abatement foam degradation/breakdown was not observed.The manufacturer is unable to directly address the symptoms outlined in the complaint.

• 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: 22113033
• Report Number: 2518422-2025-045541
• Device Sequence Number: 20622168
• Product Code: MNS
• UDI-Device Identifier: 00606959031968
• UDI-Public: (01)00606959031968
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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: 960P
• Device Catalogue Number: 960P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2013
• 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-1973-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown