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

Model Number 1100312

Device Problem Unexpected Shutdown (4019)

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

Event Date 06/06/2023

Event Type  malfunction  

Event 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
• 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: 17959267
• MDR Text Key: 325970074
• Report Number: 2518422-2023-27120
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• 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: 06/23/2023
• Date Manufacturer Received: 06/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1