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

Model Number	1060657
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
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 manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer was previously 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 manufacturer's investigation is ongoing.A follow up report will be submitted when the manufacturer's investigation is complete.In the previous report, it was submitted for customer alleging an issue related to a bipap device's sound abatement foam threatening legal action.However, after further investigation it has been determined that this should be a not reportable event.Thus, this report is not reportable at this time.

• Brand Name: BIPAP AVAPS
• 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: 16113320
• Report Number: 2518422-2023-00852
• Device Sequence Number: 6839563
• Product Code: MNS
• UDI-Device Identifier: 00606959043985
• UDI-Public: 00606959043985
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

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: 1060657
• Device Catalogue Number: 1060657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2011
• 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