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

Model Number	1101679
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/15/2026
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with a dreammapper has passed away.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported; therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Additional information has been requested regarding the details of the reported death.
Additional Manufacturer Narrative
The device on the previous report on mdr 2518422-2026-005850 is incorrect.The device is unknown and is stated correctly on this report (pr (b)(4)).
Event or Problem Description
The manufacturer received information alleging a patient with an unknown device has passed away.The reported event makes no allegation of any specific device malfunction, use error, failure, labeling, or other deficiency that is relevant to the harms reported; therefore, based on information available at this time, the device did not cause or contribute to a serious injury or death.Additional information has been requested regarding the details of the reported death.

• Brand Name: PHILIPS CPAP DEVICE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA
• Manufacturer Contact: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 24383729
• Report Number: 2518422-2026-005850
• Device Sequence Number: 10257605
• Product Code: BZD
• UDI-Device Identifier: 00606959059696
• UDI-Public: (01)00606959059696
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K152356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 1101679
• Device Catalogue Number: 1101679
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/26/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown