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

Model Number 1099966

Device Problems Fire (1245); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Codes were added in section 6 adverse event problem because they were not originally completed.

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
• Type of Device: 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
• MDR Text Key: 228180306
• Report Number: 9681154-2021-00001
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (y/n): N
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1099966
• Device Catalogue Number: 1099966
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1