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

Model Number	1126591
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer was contacted in reference to an innospire go device.The manufacturer received information alleging the device was coming apart, described as, "the bottom of the device is totally disconnected from the other part".Medical intervention was described as the patient visited urgent care in april to seek a breathing treatment due to the nebulizer "wouldn't come on".The patient's current condition is stable.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: INNOSPIRE 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: 19654408
• Report Number: 2518422-2024-41317
• Device Sequence Number: 6540470
• Product Code: CAF
• UDI-Device Identifier: 00383730002446
• UDI-Public: 00383730002446
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/02/2024

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?: Yes
• 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: 06/06/2024
• Initial Report FDA Received Date: 07/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female