MAUDE Adverse Event Report: RESPIRONICS, INC. DREAMSTATION AUTO BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	DSX700T11W
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Cancer (3262); Unspecified Respiratory Problem (4464); Unspecified Kidney or Urinary Problem (4503)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
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 nose irritation, respiratory tract irritation, kidney disease/toxicity, liver disease/toxicity, cancer.No medical intervention was specified by the patient.The device has not yet been returned to the manufacturer for evaluation.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.
Additional Manufacturer Narrative
Additional information was received on february 02, 2022, and section h11 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.The manufacturer previously received information alleging nose irritation, respiratory tract irritation, kidney disease/toxicity, liver disease/toxicity, cancer.No medical intervention was specified by the patient.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 couldn't confirm the customer's allegation and unit got corrected.In box g: date received by mfg (rfb) has been updated.In box h: evaluation method code grid, evaluation results code grid and conclusion code grid has been updated.

• Brand Name: DREAMSTATION AUTO BIPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 20457162
• Report Number: 2518422-2024-62649
• Device Sequence Number: 20803429
• Product Code: BZD
• UDI-Device Identifier: 00606959034181
• UDI-Public: (01)00606959034181
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DSX700T11W
• Device Catalogue Number: DSX700T11W
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2019
• 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-1974-2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown