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

Model Number	1100312
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer became aware of a finding of exposed wires on an innospire essence nebulizer during evaluation.The original allegations were running loud and cord where it connects is unravelled.There was no patient harm or injury.The manufacturer received the device and could not confirm the complaint of running loud, the unit had no power.There was exposed wires due to the ac wire being cut.There was no thermal damage, no voids to the enclosures.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 labeling to have a back-up device for respiratory delivery if this device is not operable.This report will be filed as an initial-final report.Based on the information available, the manufacturer concludes no further action is necessary.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section G): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD.; chichester business park; city fields way, tangmere; chichester, PO20 2FT; UK PO20 2FT
• Manufacturer Contact: kimberly shelly ; chichester business park; city fields way, tangmere; chichester, PO20 -2FT ; UK PO20 2FT
• MDR Report Key: 15182945
• Report Number: 9681154-2022-00007
• Device Sequence Number: 5809202
• Product Code: BTI
• UDI-Device Identifier: 00383730001821
• UDI-Public: 00383730001821
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1100312
• Device Catalogue Number: 1100312
• Device Lot Number: 170725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown