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

Model Number 1095060

Device Problems Device Reprocessing Problem (1091); Device Rinsing Issue (2309); Filtration Problem (2941)

Patient Problems Fever (1858); Reaction (2414)

Event Date 03/10/2014

Event Type  Injury  

Event Description

The manufacturer rec'd info that an innospire essence nebulizer was taken to a local pharmacy by the care giver where the pharmacist attempted to order a replacement nebulizer kit.The pharmacist was advised by a philips customer service representative to order a replacement through their wholesaler, thereafter the pharmacist allegedly cleaned the filter with an alcohol based solution, this action was not advised by the philips customer services representative.The patient then rec'd treatment from this device and allegedly suffered from minor symptoms such as fever and coughing.It was later confirmed that there was no further patient harm during this event.No permanent injury or patient harm was reported.

Manufacturer Narrative

Device was not returned in this instance.Device instructions for use was reviewed and clearly states that the filter is to be replaced.There was no significant patient harm and is considered as patient misuse.Manufacturer concludes that device instructions are adequate and there will be no further f/u reporting.

• Brand Name: ESSENCE COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRATORY DRUG DELIVERY GROUP (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: 3760877
• MDR Text Key: 4487039
• Report Number: 9681154-2014-00005
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2014
• 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: 1095060
• Device Lot Number: 130117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1