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

Model Number	1126591
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2024
Type of Reportable Event	Death
Event or Problem Description
Innospire go control head the manufacturer received information from the relative of a patient in reference to an innospire go device.The patient passed away on an unspecified date in 2022.The patient's cause of death was not provided by the reporter.The reporter stated the control head on the device was in need of replacement.

• Brand Name: NNOSPIRE GO
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• 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: 19782024
• Report Number: 2518422-2024-45687
• Device Sequence Number: 20902585
• Product Code: CAF
• UDI-Device Identifier: 00383730002446
• UDI-Public: 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1126591
• Device Catalogue Number: 1126591
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2021
• Initial Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown