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

Model Number 1099967

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  malfunction  

Event Description

The manufacturer received an innospire essence device for evaluation for a broken power switch.There was no patient involvement reported.The date the damage occurred is unknown.Upon receipt, it was noted the on/off switch was missing, and there was exposure to the electrical components.The root cause of the physical damage is not able to be determined.No further information has been provided by the customer.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.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).The user is advised in the product labeling if the device does not work properly to "contact your authorized product distributor or philips respironics customer service." the manufacturer will continue to monitor for trends and act appropriately.

• 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: tammy foust ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 8682571
• MDR Text Key: 147458758
• Report Number: 9681154-2019-00011
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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: 180428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2018
• 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