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

Model Number 1095060

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/16/2017

Event Type  Injury  

Event 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
• Type of Device: 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
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, west sussex PO20 -2FT ; UK PO20 2FT ; 704231549
• MDR Report Key: 6692811
• MDR Text Key: 79262992
• Report Number: 9681154-2017-00009
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 00383730001814
• Combination Product (y/n): N
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1095060
• Device Catalogue Number: 1099966
• Device Lot Number: 161014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR