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

Model Number	1095059
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pneumonia (2011); Respiratory Distress (2045)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient has had the device for a few years and the filter has never been changed.He checked the filter and it was grey so he washed it.The filter should be replaced if it is dirty.He also stated that the sidestream had not been replaced.
Event or Problem Description
It was reported that this device was not pushing the mist out well.It was also reported that the patient was admitted to hospital for fluid in her lungs, and the caregiver states that he feels this was because the patient was not receiving her full treatment.(b)(4).
Additional Manufacturer Narrative
The patient was in hospital for 7 days with pneumonia, and has since made a full recovery.The patient did not feel the pneumonia was from not getting her breathing treatments.She will not be returning the device for evaluation.
Event or Problem Description
See submission 9681154-2018-00008-307244379.

• Brand Name: INNOSPIRE ELEGANCE
• Common Device Name: COMPRESSOR, AIR, PORTABLE
• 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: 7395674
• Report Number: 9681154-2018-00008
• Device Sequence Number: 37636
• Product Code: CAF
• UDI-Device Identifier: 00383730001616
• UDI-Public: 0383730001616
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1095059
• Device Lot Number: 130614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR