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

Model Number 1099966

Device Problems Fire (1245); Smoking (1585)

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

Event Date 10/12/2020

Event Type  malfunction  

Event 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 at the power cord while the patient was using the device.The patient unplugged the device and the flames went out.There was no patient harm or injury reported.The manufacturer's investigation is on-going.Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The manufacturer received the innospire essence nebulizer for the engineering investigation.The power cord fuse was found to be intact and the power cord internal wiring passed resistance testing and is in good condition with no damage.It is suspected that the thermal event was due to a bad connection between the wall socket and the plug, resulting in the ac cord prongs having burn marks and a melted off plug.The plug prong on one side was broken which caused excessive heat dissipation which partially melted the side of the plug.This could also happen due to a loose contact on the socket side.It is hard to explain how one plug prong had broken off, but it is suspected that the user in some way caused the damage by using excessive force and applying some torque when removing the plug from the wall socket, especially if plug plastic was hot and pliable.The internal wiring and motor of the nebulizer had no thermal damage.There were no voids to the enclosures.When the device was replaced with a known good ac power cord, the unit turned on and provided pressure.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.The user is also cautioned that the power supply cord cannot be replaced by the user.In case the power supply cord becomes damaged, contact philips respironics customer service for replacement (there is no service option).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.There was no patient harm or injury reported.

• Brand Name: INNOSPIRE ESSENCE
• Type of Device: NEBULIZER,
• 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: 10816081
• MDR Text Key: 217088697
• Report Number: 9681154-2020-00009
• 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
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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
• Device Lot Number: 181107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR