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

Model Number	DS1160TS
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
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 avaps device's sound abatement foam.The patient has alleged visualization of particles.There was no report 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
Device evaluation completed.H11 updated as: 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 avaps device's sound abatement foam.The patient has alleged visualization of particles.There was no report of serious or permanent harm or injury.No medical intervention was required by the patient.The device was returned to a third-party service center.The technician confirmed no particles in the air path during the device evaluation.The third-party service center concludes that they couldn't confirm the customer's allegation, secondary findings observed and the device was 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 h6 was updated.

• 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: 19953558
• Report Number: 2518422-2024-50305
• Device Sequence Number: 8962286
• Product Code: MNS
• UDI-Device Identifier: 00606959012592
• UDI-Public: (01)00606959012592
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102465
• 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): 08/05/2025

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: DS1160TS
• Device Catalogue Number: DS1160TS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2016
• 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
• Patient Sex: Unknown