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

Model Number 1095059

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  malfunction  

Event Description

Our customer reported that the prong on the plug of this device was gone.On return of the device for evaluation, it was noted that one prong was missing from the plug.Our evaluation concluded that the plug may have been damaged by the end user applying excessive force, but there is a possibility that it broke off in the mains socket - if this was the case then a risk of exposure to a live part would be created.There is no report of any patient harm, and the device is not life-supporting or life-sustaining.The ifu for the device contains the warning 'the power supply cord cannot be replaced by the user.In case the power supply cord becomes damaged, contact philips respironics customer service for replacement (there is no service option)'.(b)(4).

• Brand Name: INNOSPIRE ELEGANCE
• 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: 5979294
• MDR Text Key: 55669827
• Report Number: 9681154-2016-00014
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1095059
• Device Catalogue Number: 1100134
• Device Lot Number: 150108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1