MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE ESSENCE; NEBULIZER SYSTEM, NON-HEATED

Model Number	R1112261
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Death
Event or Problem Description
The manufacturer received information alleging a patient with an innospire essence device has passed away.There was no allegation that the device contributed to the death.The device is missing and unavailable for return to the manufacturer for investigation.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 SYSTEM, NON-HEATED
• 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: 20311138
• Report Number: 2518422-2024-59775
• Device Sequence Number: 7792222
• Product Code: BTI
• UDI-Device Identifier: 00383730001951
• UDI-Public: (01)00383730001951
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2024

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: R1112261
• Device Catalogue Number: R1112261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2019
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown