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

Model Number	1083220
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the i-neb device displayed an error code, er66 when it was turned on, preventing the delivery of medication.The manufacturer received information alleging a chest infection.Medical intervention was required, leading to hospitalization and the administration of intravenous (iv) antibiotics.A replacement device was subsequently issued.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
This report is submitted to provide additional information from the manufacturer's final investigation findings, to include the product udi (unique device identification), and the related coding fields and date received by mfg.The manufacturer previously reported: "it was reported that the i-neb device displayed an error code, er66 when it was turned on, preventing the delivery of medication.The manufacturer received information alleging a chest infection.Medical intervention was required, leading to hospitalization and the administration of intravenous (iv) antibiotics.A replacement device was subsequently issued.The manufacturer's investigation is ongoing.The device has not yet been returned to the manufacturer for evaluation.A follow-up report will be submitted when the manufacturer's investigation is complete." despite three good faith-effort attempts on 12/03/2025, 12/06/2025, and 12/11/2025 to invoicesuk@zambongroup.Com, the device has not yet been returned to the manufacturer for evaluation.At this time, no further investigation can be completed.
Additional Manufacturer Narrative
The manufacturer previously reported a final report due to maximum gfe attempts to return the device for evaluation.Upon further review of this complaint, analysis of past events has not indicated an adverse event has occurred due to the alleged malfunction.Review of the risk file indicates the potential for a serious adverse event occurring as a result of this incident is unlikely.This complaint is considered not reportable.

• Brand Name: I NEB
• 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: 21081569
• Report Number: 2518422-2025-100098
• Device Sequence Number: 20515278
• Product Code: CAF
• UDI-Device Identifier: 00383730000909
• UDI-Public: (01)00383730000909
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K102454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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: 1083220
• Device Catalogue Number: 1083220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/09/2026; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown