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

Model Number	1099966
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received this device for evaluation in response to a user's report of "no power".There was no initial report of exposed wiring.The exact day of the reported event is unknown.Upon receipt of the device, the manufacturer noted the ac cord was stretched out by the strain relief at the nebulizer, with exposure to damaged electrical wires.There is no evidence of thermal damage on the inner wires.The root cause of the event was unable to be determined; however, it is likely the ac power cord had been exposed to forces beyond intended design.The innospire essence 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.Labeling included with the device warns the user, "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)." labeling also warns the user that the power supply cord cannot be replaced by the user.If the power cord becomes damaged, the user is instructed to contact their provider or the manufacturer for replacement as there is no service option.Based on the information available, the manufacturer concludes no further action is necessary, and will continue to monitor complaints.There was no report of patient harm or injury.

• Brand Name: INNOSPIRE ESSENCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD; chichester business park; city fields way, tangmere; chichester, gbr PO20 2FT; UK PO20 2FT
• MDR Report Key: 11496536
• Report Number: 9681154-2021-00005
• Device Sequence Number: 5169766
• Product Code: BTI
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/16/2021

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: Lay User/Patient
• Device Model Number: 1099966
• Device Catalogue Number: 1099966
• Device Lot Number: 171109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1