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

Model Number	1095060
Medical Device Problem Code	Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the caregiver that the filter of this device was very dirty as the patient had never changed it, and as a result the patient was hospitalised with what the caregiver described as 'bacteria buildup'.It also subsequently transpired that the nebuliser cups and masks had not been being cleaned regularly - but replaced monthly instead.The ifu for the compressor states 'the filter is to be replaced when it appears discolored or wet' and the ifu for the nebuliser states 'after each use, disconnect tubing from sidestream and wash all parts separately in mild liquid detergent and warm water.Rinse thoroughly and shake out excess water.Allow to air dry and reassemble.' replacement filters were provided, and the cleaning requirements explained to the caregiver.The patient has retained the device, and no further issues have been reported with it.(b)(4).

• 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, west sussex PO20 2FT; UK PO20 2FT
• MDR Report Key: 6692811
• Report Number: 9681154-2017-00009
• Device Sequence Number: 10955407
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (Y/N): N
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

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: 1095060
• Device Catalogue Number: 1099966
• Device Lot Number: 161014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/07/2017
• 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: 74 YR