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

Model Number 1099966

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2014

Event Type  malfunction  

Event Description

The mfr received info on the (b)(4) 2014 alleging a essence compressor had stopped running.There was no allegation of exposed wiring, there was no harm or injury at the time of reporting.The unit was returned to our distribution center on the (b)(4) 2014, at which time the power cord was observed to have exposed wires.(b)(4).

Manufacturer Narrative

Device received by our rdd (b)(4) facility and evaluated.The eval concluded that the device was damaged by the end user, as the power cord appeared to be damaged through excessive force/abuse which caused exposed wiring.

• 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: 4189333
• MDR Text Key: 5100356
• Report Number: 9681154-2014-00030
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1099966
• Device Catalogue Number: 1099966
• Device Lot Number: 121106
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2014
• Initial Date FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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