MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (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 08/20/2014

Event Type  malfunction  

Event Description

The manufacturer received info on (b)(4) 2014 alleging an essence compressor had a broken power cord or short.There was no allegation of exposed wiring, there was no harm or injury at the time of reporting.The unit was returned to (b)(4) on the (b)(4) 2014, at which time power cord was observed to have exposed wires.Device received by (b)(4) and evaluated.(b)(4).

Manufacturer Narrative

Evaluation concluded that the cord appeared to be damaged by a sharp tool and that caused exposed wiring.

• Brand Name: ESSENCE COMPRESSOR
• Type of Device: COMPRESSOR, AIR, PORTABLE
• Manufacturer (Section D): RESPIRONICS 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: 4122154
• MDR Text Key: 4922412
• Report Number: 9681154-2014-00026
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• 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: 130305
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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