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

Model Number	1100312
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received an allegation that the bottom of the case is melted and there is openings at the bottom of an essence nebulizer.There was no report of patient harm or injury.The manufacturer received the device for investigation.The technician confirms the initial allegations of the case is melted at the bottom and there are openings where the enclosures should meet at the bottom of the device.The technician confirms there was a thermal event that melted/warped the bottom of the compressor.The filter for the nebulizer was missing.The unit will not power on when ac power was introducted to the device.The motor does spin but is stiffer than normal.It appears the safety fuse has blown preventing an electrical thermal event.The device did experience some sort of thermal event, seizing the motor and melting the enclosure.The exact cause of the thermal event could not be confirmed.This product is intended to provide a source of compressed air for medical purposes.It is to be used with a pneumatic (jet) nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.This is not a life support device.The user is warned in the labeling to have a back-up device for respiratory delivery if this device is not operable.This report will be filed as an initial-final report.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: INNOSPIRE ESSENCE
• 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: 15328960
• Report Number: 2518422-2022-71003
• Device Sequence Number: 15043222
• Product Code: BTI
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/31/2022

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: 201216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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 Age: 2 YR
• Patient Sex: Male