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

Model Number	1112261
Medical Device Problem Codes	Failure to Power Up (1476); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging the device was not switching on and not delivering the treatment to the patient.It was reported that troubleshooting was done the device was plugged into power, tubing was fixed and then the device was tried again.The event occurred once.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 previously reported the manufacturer received information alleging the device was not switching on and not delivering the treatment to the patient.It was reported that troubleshooting was done the device was plugged into power, tubing was fixed and then the device was tried again.The event occurred once.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.This complaint has been reviewed, and it has been determined that based on information available at the time of this review, there is no evidence that the device malfunctioned in a manner that would be likely to cause or contribute to death or serious injury if it were to recur.This complaint is not reportable to any regulatory agencies.There is no report of serious patient harm or injury associated with this notification, and there is no report of medical intervention.This issue would not increase risk to the intended user.Should further investigation provide new information that impacts the outcome of the investigation or the associated medical device reporting, a supplemental report will be submitted accordingly.

• 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 ; 7247330200
• MDR Report Key: 20646591
• Report Number: 2518422-2024-103605
• Device Sequence Number: 12628555
• Product Code: CAF
• UDI-Device Identifier: 00383730001951
• UDI-Public: (01)00383730001951
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: Lay User/Patient
• Device Model Number: 1112261
• Device Catalogue Number: 1112261
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2019
• 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
• Patient Sex: Unknown