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

Model Number 1095060

Device Problems Material Split, Cut or Torn (4008); Unexpected Shutdown (4019)

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

Event Date 01/21/2021

Event Type  malfunction  

Event Description

The manufacturer received a report of a possible thermal event to an innospire essence nebulizer.The user reported she hit the power button, the device stopped working and a section of the power cord started to smoke.There was evidence of exposed wires on the power cord.There was no report of flames, or damage to the nebulizer.There was no patient harm or injury associated with this reported event.Upon receipt of the device, the manufacturer found the device working as designed.The power cord revealed a cut or pinched middle section with the exposed bare inner wires with evidence of melting.The root cause of the event was unable to be determined, however, it is likely the ac power cord had been exposed to forces beyond intended design.There were no voids to the enclosure, no thermal damage to the actual nebulizer.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 device is not labeled for life support.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)".Labeling also warns the user that the power supply cord cannot be replaced by the user.If the power cord becomes damaged, the user is instructed to contact their provider or the manufacturer for replacement as there is no service option.Based on the information available, the manufacturer concludes no further action is necessary, and will continue to monitor complaints.

• 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
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer Contact: adam price ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 11304859
• MDR Text Key: 231743163
• Report Number: 9681154-2021-00004
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001807
• UDI-Public: 00383730001807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1095060
• Device Catalogue Number: 1095060
• Device Lot Number: 190508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR