MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ESSENCE; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	1100312
Medical Device Problem Codes	Overheating of Device (1437); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the device will not mist or push out air.It is reported the side of the device's case looks to be melted but not discolored.The device was plugged into the wall.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer received information alleging the device will not mist or push out air.It is reported the side of the device's case looks to be melted but not discolored.The device was plugged into the wall.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The innospire essence was returned to the manufacturer service center for evaluation, and the customer¿s complaint was confirmed.During the evaluation it was noted that the device had an indention on one side of the top enclosure with warpage below and corresponding warpage on the bottom enclosure.The indention was jammed against the motor¿s fan blade.The motor was turned on but did not operate.Further inspection showed the motor had an open circuit.The root cause could not be confirmed at this time.The service center theorized the device came into contact with something that indented the casing and prevented the fan blade of the motor to turn thus causing the motor to have an open circuit.The devices warpage was caused by encountering a round object, due to the nature of the warpage shown in the photos, that was pressed against the device while being hot enough to cause warpage but not hot enough to discolor the device¿s enclosure.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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 ; 6501 living place; pittsburgh, PA ; 4125423300
• MDR Report Key: 20674589
• Report Number: 2518422-2024-103620
• Device Sequence Number: 20925350
• Product Code: CAF
• UDI-Device Identifier: 00383730001821
• UDI-Public: (01)00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 1100312
• Device Catalogue Number: 1100312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 08/19/2025
• 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 Age: 8 YR
• Patient Sex: Male