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

Model Number RDD482

Device Problem Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Philips internal reference no: (b)(4).The manufacture received info that a mini elite compressor did not work properly and an end user felt the need to visit an emergency room.There was no report of serious or permanent injury, and the end user returned home.The end user, who stated she is legally blind, reported that she did not read the instructions for use (ifu), and did not clean or maintain the device according to manufacturer recommendations.She has contacted her provider and replaced her nebulizer and device filters and states the device is now working properly.

Manufacturer Narrative

The mini elite compressor is not a life sustaining device.The ifu provided with the device gives full details on how to clean and maintain it.Moreover it states: "close supervision is necessary when this product is used by, on, or near children or physically challenged individuals".It is concluded by the manufacturer that the user did not follow recommended instructions, and no further action is necessary.

• Brand Name: MINIELITE
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): 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: 4861615
• MDR Text Key: 15912945
• Report Number: 9681154-2015-00011
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K060404
• 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: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RDD482
• Device Catalogue Number: RDD482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• 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: 62 YR