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

Model Number	1095059
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information that the bottom of an innospire elegance nebulizer melted.There was no report of patient harm or injury.The manufacturer received the device for evaluation and confirmed the initial complaint of the bottom of the nebulizer melted.The device did not have any power when plugged in to the ac outlet.The technician verified there was thermal warping, heat discoloration, and heavy friction damage to the bottom enclosure from the pump fan rubbing and creating a 2cm void.The thermal fuse burned on the motor, then the inline fuse opened as designed, preventing an electrical thermal event.The technician was unable to duplicate the failure of the nebulizer due to the device not having any power.This appears to possibly be caused by a motor misalignment issue which caused the fan to rub against the bottom enclosure creating heavy friction and motor-pump destabilization which led to the thermal event.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.If any additional information is received, an additional report will be filed.The manufacturer concludes no further action is needed at this time.

• Brand Name: INNOSPIRE ELEGANCE
• 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: 15282745
• Report Number: 2518422-2022-75455
• Device Sequence Number: 7166392
• Product Code: BTI
• UDI-Device Identifier: 00383730001616
• UDI-Public: 00383730001616
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2022

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: 1095059
• Device Catalogue Number: 1095059
• Device Lot Number: 210109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2021
• 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