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

Model Number	1099969
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation that an elegance nebulizer had a short in the power cord.There was no report of patient harm or injury.There was no report of medical intervention.The device has not been returned to the manufacturer.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The manufacturer received new and relevant information on 07/30/2025.The device was returned to the manufacturer¿s product investigation for investigation.The manufacturer visually inspected the device.The pil could not confirm the complaint of ¿short in the power cord¿.The motor rotated with minimal effort after it was ¿broke¿ free.The device was put back together.The power cord was plugged into the wall and the on/off switch was turned on.The motor turned on and was run for approximately 30 minutes.The device did not get hot or smell.Additional findings: the motor was locked up but once hand spun, it rotated with minimal effort.Pil determined contamination caused the motor to lock up.Section g3 and h6 have been updated in this follow up report.

• 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA 15668 ; 7247330200
• MDR Report Key: 17745945
• Report Number: 2518422-2023-22946
• Device Sequence Number: 5654297
• Product Code: BTI
• UDI-Device Identifier: 00383730001623
• UDI-Public: 00383730001623
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 10/15/2025

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 Model Number: 1099969
• Device Catalogue Number: 1099969
• Device Lot Number: 190722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2019
• 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