MAUDE Adverse Event Report: RESPIRONICS, INC.. ELEGANCE WITH SSD, 120V60HZ (US); COMPRESSOR, AIR, PORTABLE

Model Number	1100134
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of bare wires coming out of elegance nebulizer.There was no report of any thermal problems.There was no report of patient harm or injury.The device has not yet returned for evaluation.The investigation is on-going.A follow up final will be filed once the investigation is complete.
Additional Manufacturer Narrative
The manufacturer became aware of an allegation of bare wires coming out of elegance nebulizer.There was no report of any thermal problems.There was no report of patient harm or injury.The manufacturer received the device for evaluation.The technician confirms the complaint of wires are bare coming out of the device.The ac cord was cut in half.There was no signs of thermal damage or voids to the enclosures.There was evidence of customer mis-use, the top and bottom enclosures and motor were very dirty inside of the device.The output pressure was 0 psi due to no power to the machine.This is a follow up final report.The manufacturer concludes no further action is needed at this time.The manufacturer concludes no further action is needed at this time.

• Brand Name: ELEGANCE WITH SSD, 120V60HZ (US)
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS, INC..; 1001 murry ridge lane; city fields way, tangmere; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC..; 1001 murry ridge lane; city fields way, tangmere; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; city fields way, tangmere; pittsburgh, PA 15206 ; 2673970028
• MDR Report Key: 13660966
• Report Number: 9681154-2022-00004
• Device Sequence Number: 5009492
• Product Code: BTI
• UDI-Device Identifier: 00383730001630
• UDI-Public: 00383730001630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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: 1100134
• Device Catalogue Number: 1100134
• Device Lot Number: 161210
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown