MAUDE Adverse Event Report: RESPIRONICS, INC. INNOSPIRE MINI; NEBULIZING SYSTEM, NON-HEATED

Model Number	1109293
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device evaluated by third party service center.
Event or Problem Description
The manufacturer received information in relation to an innospire mini.The device was returned to a third party service center.The service center reports the device not powering on due to an ac adapter failure.There is no allegation of patient harm or serious injury.There is no allegation of medical intervention.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: INNOSPIRE MINI
• Common Device Name: NEBULIZING 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18038583
• Report Number: 2518422-2023-28241
• Device Sequence Number: 18185508
• Product Code: CAF
• UDI-Device Identifier: 00383730002019
• UDI-Public: 00383730002019
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Other
• Device Model Number: 1109293
• Device Catalogue Number: 1109293
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2017
• 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