MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ESSENCE; NEBULIZER

Model Number	1099966
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Serial number provided in complaint was not found when performed database search.(b)(6).Device returned to the manufacturer per tracking, but not yet checked into database.
Event or Problem Description
The manufacturer was contacted in reference to an innospire essence device.The reporter stated the liquid (medication) in the device would not convert to mist.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 previously reported information in reference to an innospire essence device.The reporter stated the liquid (medication) in the device would not convert to mist.There was no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.Based on the information available at this time of investigation, it has been determined that the reported allegations were against a device which is not part of the recall.In addition, there is no evidence that the device malfunctioned in a manner that would be likely to cause or contribute to death or serious injury if it were to recur.There was no patient harm or injury associated with this device and no increased risk to the intended user.Based on the information available, it is a non-reportable complaint.

• Brand Name: INNOSPIRE ESSENCE
• 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: 18620049
• Report Number: 2518422-2024-05371
• Device Sequence Number: 7398090
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170853
• 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): 06/26/2025

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: 1099966
• Device Catalogue Number: 1099966
• Device Lot Number: 181220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 06/26/2025
• 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
• Patient Sex: Unknown