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

Model Number	ITX500S15
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	07/16/2023
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 patient alleges that following the suspension of the use of the respirator, they were hospitalized due to the onset of arterial instability due to hypertension and had biologic damage.The device has not yet been returned to the manufacturer for evaluation.Customer contact information was unavailable to gather additional information for evaluation and investigation.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
As 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.H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
**udi related data quality updates only** the udi in section d4 was previously reported in the incorrect format.The udi information has been updated to the correct format.Sections d1 and d4 updated.
Additional Manufacturer Narrative
The manufacturer received new and relevant information on 09/26/2025.The medical device associated with this complaint is currently under legal hold.As a result, philips is unable to proceed with device evaluation activities.This restriction prevents access to the device for inspection, testing, or analysis.If additional information becomes available, philips will assess the according to regulatory obligations and perform any necessary reporting activities to the appropriate competent authorities.Section g3 and h6 have been updated in this follow up report.

• Brand Name: DREAMSTATION AUTO CPAP
• 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: 17981370
• Report Number: 2518422-2023-27494
• Device Sequence Number: 16757809
• Product Code: BZD
• UDI-Device Identifier: 00606959027275
• UDI-Public: (01)00606959027275
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: ITX500S15
• Device Catalogue Number: ITX500S15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: Not provided; 09/26/2025
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 08/14/2024; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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