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

Model Number	1106648
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation that an elegance nebulizer would not power on.There was no report of patient harm or injury.The manufacturer received the device for evaluation and could confirm the customer's allegation that the device would not turn on.In addition, it was determined there were burn marks inside the top casing, thermal damage to the motor plastic casing, and exposed wires due to thermal damage.This report will be submitted as an initial final.The manufacturer concludes no further action is needed at this time.

• Brand Name: ELEGANCE NEBULIZER
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16772018
• Report Number: 2518422-2023-09290
• Device Sequence Number: 6436961
• Product Code: BTI
• UDI-Device Identifier: 00383730002798
• UDI-Public: 00383730002798
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care 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: Lay User/Patient
• Device Model Number: 1106648
• Device Catalogue Number: 1106648
• Device Lot Number: 190322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2019
• 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