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

Model Number	1100312
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported the device innospire essence with the allegation of shutting off.The manufacturer received the device for investigation.The technician confirms the device not powering on, damaged power cord.They found medium amounts of contamination: dirt, dust, debris, and hair inside the device.The evidence of device being used without npc filter installed eventually contaminates throughout the npc filter port on and inside the motor/pump.Also, a loose eccentric subassembly oil cap has separated enough to start leaking oil.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: 17959267
• Report Number: 2518422-2023-27120
• Device Sequence Number: 7007048
• Product Code: CAF
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,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: 06/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 10/18/2023
• 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: Unknown