MAUDE Adverse Event Report: RESPIRONICS, INC. BIPAP AUTOSV ADV; N-LIFE-SUPPORTINVENTILATOR, CONTINUOUS, NOG

Model Number	FR965S
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
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 dreamstation auto cpap device's sound abatement foam.There was no report of 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 previously reported 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 dreamstation auto cpap device's sound abatement foam.There was no report of harm or injury.No medical intervention was required by the patient.After receiving further information from the patient it is determined that the initial report should have been filed as product problem only.Section adverse event/product problem in box b, section type of reported complaint and health impact grid in box h has been updated/corrected in this report.

• Brand Name: BIPAP AUTOSV ADV
• Common Device Name: N-LIFE-SUPPORTINVENTILATOR, CONTINUOUS, NOG
• Manufacturer (Section D): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer (Section G): RESPIRONICS, INC.; 6501 living place; pittsburgh PA 15208
• Manufacturer Contact: melissa rosko ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 19448912
• Report Number: 2518422-2024-33554
• Device Sequence Number: 20959363
• Product Code: BZD
• UDI-Device Identifier: 00606959029712
• UDI-Public: 00606959029712
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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: FR965S
• Device Catalogue Number: FR965S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2013
• 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