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

Model Number	DSX900T11
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Cancer (3262)
Date of Event	07/15/2024
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 cancer and patiently waiting for device for 6 months and need the device as soon as possible.No medical intervention was specified by the patient.No additional information can be requested at this time.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
The dreamstation bipap autosv was returned to the manufacturer for investigation.The device was applied power and verified airflow.During the investigation, pil observed the following from an external and internal inspection: potential no clean flux on the sd (secure digital) card slot on the pca (printed circuit assembly).Hairlike fibers on the interior of the ui (user interface) panel and the interior of the bottom enclosure.A dust like contaminate on the ui panel, ui knob, top enclosure, keypad, rear panel, bottom enclosure, accessory module and sd cover flip doors, philips pollen filter, blower motor, and the blower box.The device was missing the sd card.A keratin-like substance was observed on the blower box outlet.Er-2243857 v.01 addresses the issue of keratin.There is no visible damage or functionality failures of the device, which suggests that the source of contamination was external to the device.Evidence of sound abatement foam degradation/breakdown was not observed in the base unit.The manufacturer confirmed that there was no presence of degraded sound abatement foam using a fitt and the associated procedure.There was no visible damage or functionality failures of the device, which suggests that the source of contamination was external to the device.The manufacturer was unable to directly address the symptoms outlined in the complaint.In this report, box d, h has been updated/corrected.

• Brand Name: DREAMSTATION BIPAP AUTOSV
• 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 ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 19888767
• Report Number: 2518422-2024-48606
• Device Sequence Number: 12707131
• 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
• Report Date (Section B): 12/02/2025

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: DSX900T11
• Device Catalogue Number: DSX900T11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown