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

Model Number	DSX900T11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.There was no report of medical intervention.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 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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.There was no report of medical intervention.Repeated attempts to have the device and components returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.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: evaluation method code grid.Evaluation results code.Conclusion code grid has been updated.
Additional Manufacturer Narrative
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 visualization of particles related to a cpap device's sound abatement foam.There was no report of patient harm or injury.There was no report of medical intervention.The device was returned to the third-party service center for further evaluation.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation.During the evaluation connector oxide was observed.The third-party service center concludes that they couldn't confirm the customer's allegation and there was no visible foam degradation.Section-h has been updated.

• Brand Name: DREAMSTATION BIPAP AUTO SV
• 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: 21616887
• Report Number: 2518422-2025-035397
• Device Sequence Number: 8516120
• Product Code: MNS
• UDI-Device Identifier: 00606959424371
• UDI-Public: (01)00606959424371
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090539
• 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,Followup
• Report Date (Section B): 07/24/2025

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: DSX900T11
• Device Catalogue Number: DSX900T11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/16/2025; 07/07/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/02/2025; 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2020
• 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