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

Model Number	1100134
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of unit has low flow from a dme regarding an elegance nebulizer.There was no report of patient harm or injury, no report of exposed wires or thermal issues.The manufacturer received the device for investigation.The unit has no power, so we are unable to confirm the complaint of unit has low flow.The ac power cord has a faulty plug, one of the prongs has broken off.There was no evidence of thermal damage, no voids or damage to the enclosures.There were no exposed wires.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: NEBUIZER 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: 16113121
• Report Number: 2518422-2023-00822
• Device Sequence Number: 14891475
• Product Code: BTI
• UDI-Device Identifier: 00383730001630
• UDI-Public: 00383730001630
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (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: 1100134
• Device Catalogue Number: 1100134
• Device Lot Number: 210619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2021
• 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