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

Model Number	1100312
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacture received this device for evaluation in response to a report of a "bad power cord".One of the prongs has broken off.There was no patient harm or injury.The exact date of the reported event is unknown.During the evaluation, it was noted the power cord was missing on 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 its 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 necessary, and will continue to monitor complaints.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: 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
• MDR Report Key: 11648565
• Report Number: 9681154-2021-00010
• Device Sequence Number: 3499003
• Product Code: CAF
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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: Other
• Device Model Number: 1100312
• Device Catalogue Number: 1100312
• Device Lot Number: 190807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1