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

Model Number	1126593
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
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 has oxidized charging ports.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 innospire go device has oxidized charging ports.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.Analysis of past events has not indicated an adverse event has occurred due to corrosion.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.Additionally, the risk file indicates that corrosion will not substantially affect the performance of the device.This complaint is considered not reportable.

• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18349841
• Report Number: 2518422-2023-36281
• Device Sequence Number: 5531449
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup

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: Health Professional
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2022
• 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