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

Model Number RDD482

Device Problems No Device Output (1435); Device Inoperable (1663)

Patient Problem Asthma (1726)

Event Date 10/15/2014

Event Type  No Answer Provided  

Event Description

The mfr received info alleging that a mini elite ceased to function, thereafter the pt did not administer any medication for three weeks, the pt was then hospitalized with an asthma attack.The device has not yet been returned to the mfr for eval.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the mfr's investigation is complete.(b)(4).

• Brand Name: MINI ELITE
• 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: 4254832
• MDR Text Key: 16861815
• Report Number: 9681154-2014-00036
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1