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

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

The manufacturer received information related to an innospire elegance device.The user did not provide specific device information, such as serial number.The user alleges receiving the device in (b)(6) 2022 and using the device 2-3 times daily.The user alleges using the device 20-25 minutes prior to a thermal event.The allegation is that the device began to smoke and charred the top.The user alleges unplugging the device right away.The user was advised to return the device to their dme.There is no report of patient harm or serious injury.There is no allegation of medical intervention.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• Brand Name: INNOSPIRE ELEGANCE
• 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: 18049023
• MDR Text Key: 327088279
• Report Number: 2518422-2023-28476
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1