MAUDE Adverse Event Report: RESPIRONICS, INC. ESSENCE WITH SSD & SSR; COMPRESSOR/NEBULIZER

Model Number	1100312
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of an allegation of a thermal event.The user reported smoke and overheating of the device causing the device to melt.An odor was also observed.The manufacturer received the device for investigation.The technician confirms heavy signs of thermal damage, as well as a dirty npc filter.The technician confirms there was a thermal event that melted/warped the plastic.There was much debris, dirt, dust found once the device was broken down.The technician found no evidence of thermal events such as smoke, wires melting, or other related electrical fire evidence.Heavy rust was found showing a damp environment.The technician determined that use of the device with dirty filters for so long contaminates throughout the npc filter port, then inside the motor pump causing failures.The exact cause of the thermal event could not be confirmed.There was no patient harm or injury.The manufacturer concludes that no further action is necessary at this time.

• Brand Name: ESSENCE WITH SSD & SSR
• Common Device Name: COMPRESSOR/NEBULIZER
• 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: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 17805484
• Report Number: 2518422-2023-24263
• Device Sequence Number: 6727374
• Product Code: CAF
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K170853
• 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

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/25/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Female