MAUDE Adverse Event Report: RESPIRONICS, INC.. INNOSPIRE ESSENCE NEBULIZER; COMPRESSOR, AIR, PORTABLE

Model Number	1100312
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware that an essence nebulizer was not working.There was no report of smoking, flames or exposed wires.The nebulizer was returned for evaluation and the technician found evidence of a milky contaminate throughout the inside and outside of the device.It appears the liquid contamination made its way inside the switch from the top of the enclosure causing verdigris and a short.This short melted the internal power cables at the on/off switch, and melted into the npc buffer tube causing a hole in the buffer cylinder and damaged the surrounding area.There was no allegations of harm or injury.The manufacturer confirmed the complaint of device not working due to the thermal damage inside the machine at the on/off switch.The root cause could be the switch itself had an internal short, the insulated connection tabs as the end of the white and black internal power wires may have had a fuilure or the liquid contamination had caused the thermal event.The nebulizer had evidence of grime, dirt, debris and a black powdery substance falling from the vents.There was no air filter in place.Labeling warns: any liquid spilled on or inside the unit should be allowed to dry before operating.The manufacturer will submit this report as an initial final.The manufacturer concludes no further action is needed at this time.

• Brand Name: INNOSPIRE ESSENCE NEBULIZER
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• 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 15206 ; 2673970028
• MDR Report Key: 15692566
• Report Number: 2518422-2022-87903
• Device Sequence Number: 12462932
• Product Code: BTI
• UDI-Device Identifier: 00383730001807
• UDI-Public: 0100383730001807
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2022

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
• Device Lot Number: 201106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown