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

Model Number	1095060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Failure (2484)
Date of Event	02/21/2025
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with an innospire essence nebulizer has passed away.It was alleged the nebulizer was defective and stated that the device was subsequently recalled.It is alleged that use of the device caused or contributed to worsening of the patient¿s respiratory condition.The patient subsequently passed on (b)(6) 2025.The device has not yet been returned to the manufacturer for evaluation.If any additional information is received, a follow-up report will be filed.
Additional Manufacturer Narrative
The manufacturer previously reported information alleging a patient with an innospire essence nebulizer has passed away.It was alleged the nebulizer was defective and stated that the device was subsequently recalled.It is alleged that use of the device caused or contributed to worsening of the patient¿s respiratory condition.The patient subsequently passed on (b)(6) 2025.The device has not yet been returned to the manufacturer for evaluation.No additional information can be requested at this time.The manufacturer was made aware of this complaint through a representative of the customer.At this time, no further investigation can be performed.If any additional information is received, a follow- up report will be filed.

• Brand Name: INNOSPIRE ESSENCE
• 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 ; +1(724)733-0200
• MDR Report Key: 24571611
• Report Number: 2518422-2026-009175
• Device Sequence Number: 8568419
• Product Code: CAF
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 1095060
• Device Catalogue Number: 1095060
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Unknown