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

Model Number 1099966

Device Problems Electrical /Electronic Property Problem (1198); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The manufacturer received info on (b)(4) 2014 alleging a innospire essence compressor had no airflow.It was later discovered by philips on (b)(4) 2014 that there are exposed wires.There was no reported harm or injury to the pt.(b)(4).

Manufacturer Narrative

The evaluation concluded that the device may have been damaged by the end user or an animal, as the power cord appeared to be damaged through excessive force/abuse which caused exposed wiring.

• Brand Name: INNOSPIRE ESSENCE
• 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: 4320885
• MDR Text Key: 18258040
• Report Number: 9681154-2014-00039
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• 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: 140220
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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