MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD INNOSPIRE ESSENCE; NEBULIZING SYSTEM, NON-HEATED

Model Number 1099967

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Event Description

An innospire essence device was received by the manufacturer for a report that is was faulty.Upon receipt of the device, the manufacturer noted physical damage to the ac power source, which resulted in exposed conducting wires, and a risk of shock to the user.There was no report of patient harm or injury.The date of the occurrence of the damage is unknown.There were no other defects noted to the device.Although the root cause of the observed damage was not confirmed, this type of damage is typically a result of the ac power cord being subjected to forces beyond intended design.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 instructions for use: "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)." this device meets all relevant ul and iec standards.The manufacturer will continue to monitor for similar complaints.

• Brand Name: INNOSPIRE ESSENCE
• Type of Device: NEBULIZING SYSTEM, NON-HEATED
• 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: 8391698
• MDR Text Key: 137866676
• Report Number: 9681154-2019-00006
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 1099967
• Device Catalogue Number: 1099967
• Device Lot Number: 160427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Date Manufacturer Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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