MAUDE Adverse Event Report: RESPIRONICS, INC. ASSAY FOR ESSENCE PLUG; NEBULIZER SYSTEM, NON-HEATED

Model Number	1095060
Medical Device Problem Codes	Failure to Power Up (1476); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging an issue related to an assay for essence plug device with allegation of device is smoking and not turning on.There was no report of patient harm or injury.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Additional information was received on aug 13, 2024.The manufacturer previously received information alleging an issue related to an assay for essence plug device with allegation of device is smoking and not turning on.There was no report of patient harm or injury.The device was returned to the manufacturers product investigation laboratory for investigation.There was no evidence of smoke residue internal or external.The motor was able to be rotated with minimal effort.The manufacturer did notice the buffer cylinders port was plugged with a gel-like substance and there were foreign brown substances on the bottom enclosure in several areas.The manufacturer tested the on/off switch with a multimeter.It did not ohm out indicating it was defective and there was an external side of the on/off switch, foreign brown particles could be seen.This was reminiscent of a liquid contacting the switch.This could account for the complaint and the switch not working.Evaluation method code grid, evaluation results code grid, component code grid and conclusion code grid was updated.

• Brand Name: ASSAY FOR ESSENCE PLUG
• Common Device Name: NEBULIZER SYSTEM, NON-HEATED
• 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: 19804822
• Report Number: 2518422-2024-46465
• Device Sequence Number: 12611120
• Product Code: BTI
• UDI-Device Identifier: 00383730001807
• UDI-Public: (01)00383730001807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1095060
• Device Catalogue Number: 1095060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown