MAUDE Adverse Event Report: RESPIRONICS, INC. CUSTOM ELEGANCE WITH SIDESTREAM PLUS; NEBULIZER

Model Number 1102828

Device Problems Device Emits Odor (1425); Excessive Heating (4030)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

The manufacturer was contacted in reference to innospire elegance device.The manufacturer received information alleging the unit was hot and had a burning smell while in use.There is no allegation of serious or permanent harm or injury.No medical intervention was required by the patient.No warping, melting, voids/gaps, smoke, or flames were reported.The device was returned to the manufacturer, and during evaluation the technician was unable to confirm the thermal event.The device was visually inspected and no signs of thermal or other events were visible on the plastic parts of the device.The npc filter was inserted and dirty.The nebulizer was connected to test bench where power was applied and the device power's on, fan spins, but pump engages, light amount of medicine dispersing indicating little to no pressure.Light environmental contamination (the inside of the device appears to have been recently cleaned): dirt, dust, and debris attached to the fan and pump assembly.No noticeable thermal or damage inside the device.Upon disassembly of the unit verifying only low pressure at 1.4 psi.There is evidence of lubricant leakage, internal pump-contamination, and piston-seal failure.Over time contamination will eventually cause the motor to overheat, seals to fail, premature eol issues, or eventually total mechanical seizure.The root cause of the complaint was determined to be possible contamination and/or a ventilation issue.The wear and tear may have been caused from contamination, and/or using with/without a dirty npc filter installed.This degraded performance is linked to internal motor/pump contamination that is being sucked inside through the npc air inlet port during each use.Eventually it wears the seals, lowering performance, and causing early end of life (eol) issues to the device.

• Brand Name: CUSTOM ELEGANCE WITH SIDESTREAM PLUS
• Type of Device: 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: 18166301
• MDR Text Key: 328940621
• Report Number: 2518422-2023-31031
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730002385
• UDI-Public: 00383730002385
• 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

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1102828
• Device Catalogue Number: 1102828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Date Manufacturer Received: 10/19/2023
• 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