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

Model Number 1099969

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Event Description

The manufacturer received this device for evaluation in response to the report of a "broken power cord".There was no patient involvement.During the evaluation, it was noted the power cord was missing one of its prongs, exposing the user to a possible shock.The root cause of the physical damage is unknown, however it is likely the power cord was exposed to forces beyond intended design.The innospire elegance device 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 children and adults.Labeling warns the "it is recommended to have a backup device for respiratory delivery in case a situation arises when your nebulizer can not be used".This device is not labeled for life support.This device meets all relevant ul and iec standards.Based on the information available, the manufacturer concludes no further action is required.

• Brand Name: INNOSPIRE ELEGANCE
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, uk PO20 2FT; UK PO20 2FT
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, uk PO20 2FT; UK PO20 2FT
• Manufacturer Contact: tammy foust ; chichester business park; city fields way, tangmere; chichester, uk PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 8470273
• MDR Text Key: 140510186
• Report Number: 9681154-2019-00007
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1099969
• Device Catalogue Number: 1099969
• Device Lot Number: 160517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2016
• 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