MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE ESSENCE; COMPRESSOR, AIR, PORTABLE

Model Number	1095060
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer was made aware by an end user that a thermal event occurred with an innospire essence device.There was no patient harm or injury associated with the reported event.The user reported that the machine was turned on and in use when they noticed the device began to smoke and flames were coming from the device.The user unplugged the device and took it outside where the flames then self-extinguished.The manufacturer requested the return of the device for investigation; however, the user disposed of the device and will not be returning it to the manufacturer.The root cause of the reported event is unable to 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 backup device for respiratory delivery if this device is not operable.Based on the information available, the manufacturer concludes no further action is necessary, and will continue to monitor complaints.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• MDR Report Key: 9957768
• Report Number: 9681154-2020-00005
• Device Sequence Number: 2764724
• Product Code: BTI
• UDI-Device Identifier: 00383730001807
• UDI-Public: 00383730001807
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1095060
• Device Catalogue Number: 1095060
• Device Lot Number: 160705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1