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

Model Number	1100312
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of a user of an essence nebulizer alleging that the cover on the compressor was cracked and the user was concerned that it may be affecting the output of their medication.There was no report of serious harm or injury.The device was returned to the manufacturer's service center for further evaluation.During the evaluation of the device the manufacturer confirmed that the top enclosure of the compressor was cracked, and outlet tube was cracked affecting output of medication.The unit was scrapped.The manufacturer concludes that the complaint was confirmed.
Additional Manufacturer Narrative
The manufacturer previously reported they became aware of a user of an essence nebulizer alleging that the cover on the compressor was cracked and the user was concerned that it may be affecting the output of their medication.There was no report of serious harm or injury.The device was returned to the manufacturer's service center for further evaluation.During the evaluation of the device the manufacturer confirmed that the top enclosure of the compressor was cracked, and outlet tube was cracked affecting output of medication.The unit was scrapped.The manufacturer concludes that the complaint was confirmed.Udi related data quality updates only.Previously the udi in section d4 was reported in the incorrect format.The udi format has been corrected.

• 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 ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17909942
• Report Number: 2518422-2023-25784
• Device Sequence Number: 20492165
• Product Code: BTI
• UDI-Device Identifier: 00383730001821
• UDI-Public: (01)00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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: 1100312
• Device Catalogue Number: 1100312
• Device Lot Number: 221021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown