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

Model Number	CAX700T12
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Rhinitis (4876)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to a bipap device's sound abatement foam.There was no report of patient harm or injury.This issue was reported to the fda per 21 cfr 806.The device will be corrected per res (b)(4).
Additional Manufacturer Narrative
H11: b5- 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 an issue related to cpap/bipap device's sound abatement foam.The patient alleged that the visualization of particles.The patient alleged nasal allergies.H10: additional information was received on 09/27/2023.The device was returned to the manufacturer's service center for further evaluation.There was no mention of visual findings to the external part of the device.The internal aspect of the device was inspected.The device powered on, and the airflow was confirmed.The device's downloaded logs were reviewed.The manufacturer concludes that the customer allegation could not be confirmed and there was no visible foam degradation.The unit has been scrapped.Sections d8, d9, h3 and h6 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 ; 7243512041
• MDR Report Key: 12495153
• Report Number: 2518422-2021-04120
• Device Sequence Number: 4111953
• Product Code: BZD
• UDI-Device Identifier: 00606959026667
• UDI-Public: 00606959026667
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K131982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: CAX700T12
• Device Catalogue Number: CAX700T12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2016
• 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
• Usage of Device: Unknown
• 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