MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION BIPAP AVAPS30; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number	DSX1130T11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since no device information was provided, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.
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.There was no allegation reported by the patient.There was no report of serious patient harm or injury.There was no report of medical intervention.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.The device has not been returned to the manufacturer.At this time, no further investigation can be requested.If any additional information is received, a supplemental report will be filed.
Additional Manufacturer Narrative
The manufacturer received device information.In this report, box d, g, h has been updated/corrected.
Additional Manufacturer Narrative
Additional information was received, and section h should be reported 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.There was no allegation reported by the patient.There was no report of serious 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.The third-party service center concludes that they could not confirm the customer's allegation and there was no visible foam degradation and unit got scrapped.In box h: evaluation method code, evaluation results code, component code and conclusion code grid has been updated.

• Brand Name: DREAMSTATION BIPAP AVAPS30
• 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: 21188972
• Report Number: 2518422-2025-004816
• Device Sequence Number: 8786448
• Product Code: MNS
• UDI-Device Identifier: 00606959424425
• UDI-Public: (01)00606959424425
• 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,Followup
• Report Date (Section B): 07/23/2025

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: DSX1130T11
• Device Catalogue Number: DSX1130T11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 06/04/2025; 02/28/2023
• Initial Report FDA Received Date: 01/20/2025
• Supplement Report FDA Received Date: 06/04/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2018
• 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