MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE ESSENCE; NEBULIZER, PRODUCT CODE:

Model Number	1099966
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a report of a possible thermal event to an innospire essence nebulizer.The device allegedly started smoking and flames were seen while the patient was using the device.The patient unplugged the device and threw it outside.There was no patient harm or injury reported.The patient discarded the device.The serial number and lot number are missing, therefore the date of manufacture is unable to be determined.The exact date of the reported event is unknown.The innospire essence 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.Labeling included with the device warns the user, "it is recommended to have a backup device (e.G.Mdi or battery-operated compressor) for respiratory delivery in case a situation arises when your nebulizer cannot be used (e.G.During a power outage or if your compressor becomes inoperable for any reason)." the manufacturer will continue to monitor the complaint records for similar reported failures.Based on the available information, the manufacturer concludes no further action is necessary.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: NEBULIZER, PRODUCT CODE:
• 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: 10138582
• Report Number: 9681154-2020-00010
• Device Sequence Number: 11303743
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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: 1099966
• Device Catalogue Number: 1099966
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1