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

Model Number 1109293

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device evaluated by third party service center.

Event 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
• Type of Device: 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
• MDR Text Key: 326960759
• Report Number: 2518422-2023-28241
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730002019
• UDI-Public: 00383730002019
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1109293
• Device Catalogue Number: 1109293
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1