MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC ELEGANCE NEBULIZER; NEBULIZER SYSTEM, NON-HEATED

Model Number	1099969
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of an elegance nebulizer that was not turning on.There was no patient harm or injury, no allegations of thermal damage, no voids or exposed wires were reported.The manufacturer received the device for investigation and confirmed the allegation of device not turning on.There was no power due to damage to the ac power cord.Wires were out of the strain relief, the ac power cord had exposed copper conductors.There was physical damage to the con-rod, which was detached from the compressor.There was no evidence of thermal damage or voids to the enclosures.This report will be submitted as an initial final.There was no patient harm or injury.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): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 1001 murry ridge lane; ste a; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 16112565
• Report Number: 2518422-2023-00779
• Device Sequence Number: 5753659
• Product Code: BTI
• UDI-Device Identifier: 00383730001623
• UDI-Public: 00383730001623
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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
• Device Model Number: 1099969
• Device Catalogue Number: 1099969
• Device Lot Number: 190219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2019
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown