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

Model Number	999998
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Death
Event or Problem Description
Manufacturer received a call from the patient's relative asking what to do with the machine, because the patient has passed away.It is unclear if an event may have caused or contributed to the patient's death.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
Event or Problem Description
The manufacturer received a call from the patient's relative asking what to do with the philips cpap device, because the patient had passed away.It is unclear if an event may have caused or contributed to the patient's death.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.
Additional Manufacturer Narrative
This report is submitted to correct the previously reported device.The device was incorrectly identified as a dreammapper.All other device information is currently unknown, and the device will be classified as a philips cpap device.
Additional Manufacturer Narrative
Manufacturer received a call from the patient's relative asking what to do with the machine, because the patient has passed away.It is unclear if an event may have caused or contributed to the patient's death.The manufacturer is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.This report is submitted to correct the previously reported device.The device model number and catalog item identifier have been updated to 999998 in box d: suspect medical device since the device is unknown.
Additional Manufacturer Narrative
The manufacturer previously reported 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.Multiple good faith efforts have been made to obtain additional information, without customer response.A final report is being submitted.If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a follow up/supplemental report will be completed.

• 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: 22903537
• Report Number: 2518422-2025-109392
• Device Sequence Number: 15431456
• 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
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2026

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: 999998
• Device Catalogue Number: 999998
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided; 02/09/2026; 04/14/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 01/20/2026; 02/09/2026; 04/29/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown