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

Model Number	1126593
Medical Device Problem Codes	Failure to Power Up (1476); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
The manufacturer received information alleging a innospire go device is providing small doses and stops after a short run.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 alleging a innospire go device is providing small doses and stops after a short run.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The previous report incorrectly stated the device is providing small doses.The device is only reported to be stopping after a short run.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a innospire go device is providing the device is only reported to be stopping after a short run.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.The previous report incorrectly stated the device is only reported to be stopping after a short run.The user of the device states that the device cannot be launched.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.
Additional Manufacturer Narrative
Despite multiple attempts on 1/2/2025, 1/8/2025, 1/13/2025 the device has not yet returned to the manufacturer for evaluation.There has been no response from the customer on the return of the device.At this time, no further investigation can be performed.If any additional information is received, a follow up report will be filed.In this report, box h has been updated/corrected.

• Brand Name: INNOSPIRE GO
• 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: 18258628
• Report Number: 2518422-2023-33332
• Device Sequence Number: 7691527
• Product Code: CAF
• UDI-Device Identifier: 00383730000534
• UDI-Public: 00383730000534
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K170853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 1126593
• Device Catalogue Number: 1126593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 11/17/2023; 05/12/2025
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 12/05/2023; 12/06/2023; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2022
• 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
• Patient Sex: Unknown