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

Model Number 1099966

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Asthma (1726)

Event Date 09/24/2018

Event Type  malfunction  

Event Description

An end user alleges she purchased an innospire essence compressor to aid in treatment of her chronic asthma and found it was missing the nebulizer medication cup upon first use "two to three weeks" after purchase.The user stated she was unable to perform a breathing treatment, and as a result went to the emergency room and was reportedly admitted.There was no report of serious or permanent injury.The user was discharged the next day.It is unknown if the user attempted to administer her aerosol medication using another method prior to going to the emergency room.The manufacturer attempted numerous times to obtain more information from the user.No further information has been provided by the user.No product has been returned for investigation.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)." there was no serious or permanent injury.Based on the information available, the manufacturer concludes no further action is necessary at this time.If further information becomes available, or the device is returned for investigation, the manufacturer will file a supplemental report.

• Brand Name: INNOSPIRE ESSENCE
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, po20 PO20 2FT; UK PO20 2FT
• Manufacturer Contact: tammy foust ; chichester business park; city fields way, tangmere; chichester, hampshire, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 7965609
• MDR Text Key: 123955456
• Report Number: 9681154-2018-00020
• Device Sequence Number: 1
• Product Code: CAF
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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: 171207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR