MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADV SYS ONE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	IN961S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
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 bipap device's sound abatement foam.The patient has alleged to seeing particles in the air path.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.

• Brand Name: BIPAP AUTOSV ADV SYS ONE
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16407915
• Report Number: 2518422-2023-05288
• Device Sequence Number: 6327256
• Product Code: BZD
• UDI-Device Identifier: 00606959029620
• UDI-Public: 00606959029620
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K090539
• 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

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: IN961S
• Device Catalogue Number: IN961S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2015
• 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: RES 88058
• Patient Sequence Number: 1
• Patient Sex: Unknown