MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE ESSENCE; NEBULIZER, (DIRECT PATIENT INTERFACE)

Model Number	1099966
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
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 user reported he was using the nebulizer and then shut it off.When he came back into the room, the nebulizer allegedly was on fire.He unplugged the nebulizer and threw it outside.There was no patient harm or injury reported.The manufacture's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.
Additional Manufacturer Narrative
Codes were added in section 6 adverse event problem because they were not originally completed.
Additional Manufacturer Narrative
The manufacturer previously reported receiving information alleging a thermal event to an essence nebulizer.There was no harm or injury reported.Repeated attempts to have the device returned for evaluation and investigation were unsuccessful.The manufacturer believes they will be unable to gather additional information.The manufacturer is submitting a final report at this time.If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: NEBULIZER, (DIRECT PATIENT INTERFACE)
• 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: 11170193
• Report Number: 9681154-2021-00001
• Device Sequence Number: 3512818
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2021

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 12/29/2020; 03/05/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 02/16/2021; 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1