MAUDE Adverse Event Report: RESPIRONICS, INC. DELUXE 230V 50HZ INT. UK PLUG; NEBULIZER

Model Number	1112279
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	10/31/2023
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a unit is lost and that the patient has passed away.There was no allegation of a specific malfunction or failure that is relevant to the reported death.Medical intervention was not specified.A pms clinical expert review determined that this event is not assessable for injury or relatedness based on the information provided at this time.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This incident was previously reported in mfr no.: 2518422-2025-022331.After careful review, it has been found that this case is not reportable as the device is not manufactured by philips.

• Brand Name: DELUXE 230V 50HZ INT. UK PLUG
• Common Device Name: NEBULIZER
• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 21462483
• Report Number: 2518422-2025-022331
• Device Sequence Number: 7781785
• Product Code: CAF
• UDI-Device Identifier: 06946159502023
• UDI-Public: (01)06946159502023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K031413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 1112279
• Device Catalogue Number: 1112279
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2022
• 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