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

Model Number 1095059

Device Problem Insufficient Information (3190)

Patient Problems Pneumonia (2011); Respiratory Distress (2045)

Event Date 03/06/2018

Event Type  Injury  

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 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).

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 Description

See submission 9681154-2018-00008-307244379.

• Brand Name: INNOSPIRE ELEGANCE
• Type of Device: 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
• MDR Text Key: 104285650
• Report Number: 9681154-2018-00008
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001616
• UDI-Public: 0383730001616
• Combination Product (y/n): N
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

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