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

Model Number	1126591
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a user of an innospire go device reports it is not working.The patient reports the device is not nebulizing the medication and the light is blinking on then off.The nebulizer was rinsed out with water in the medicine cup and plugged into the wall.Afterwards the light is no longer blinking and still no mist is coming out.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 a user of an innospire go device reports it is not working.Clinical expert reviewed the event and based on the information currently provided and available, no harm or injury has been sustained and therefore further analysis of cause and/or contribution of the device to a serious injury or death is not applicable.This event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, and/or reportable product malfunction.

• Brand Name: INNOSPIRE GO
• 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 ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 21939564
• Report Number: 2518422-2025-105023
• Device Sequence Number: 12961776
• Product Code: CAF
• UDI-Device Identifier: 00383730002446
• UDI-Public: (01)00383730002446
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 1126591
• Device Catalogue Number: 1126591
• Device Lot Number: 1908
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2020
• 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