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

Model Number RDD490

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2015

Event Type  malfunction  

Event Description

The mfr received info on the (b)(6) 2015 alleging compressor had no power and that there were exposed wires.There was no reported harm or injury ot the patient.The device has not been returned to date to allow further investigation.(b)(4).

Manufacturer Narrative

(b)(4).Despite numerous attempts to retrieve the device for investigation, no product has been returned.The manufacturer is unable to confirm the allegation the "power cord has a short with exposed wires".Rdd490 is a dc compressor that is powered by an ac/dc power adaptor.The only wire in this device is in the dc circuit of the power adaptor which would pose no risk to the intended user.Instruction for use states:"never operate this product if it has a damaged cord or plug".Based on the information provided, the manufacturer concludes no further action is necessary.The compressor was manufactured in january, 2013.

• Brand Name: MICRO ELITE
• 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; tangmere; chichester, PO202-FT ; UK PO202FT ; 8704231549
• MDR Report Key: 5004439
• MDR Text Key: 24095868
• Report Number: 9681154-2015-00012
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Not Applicable
• Type of Report: Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RDD490
• Device Catalogue Number: RDD490
• Device Lot Number: 131
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: No
• 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