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

Model Number 1100312

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 324495446
• Report Number: 2518422-2023-24263
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female