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

Model Number	1095059
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device had low air flow.On return of the device for evaluation, it was noted that the mains cord had been severed and the plug was missing.This has led to exposed mains wires, which poses no hazard itself as the device cannot now be connected to a mains supply.However, it has not been established how the plug came to be missing, and there is a possibility that it broke off in the mains socket - if this was the case then a risk of electrocution would be created.Our evaluation concluded that in all likelihood the cord was severed by the end user applying excessive force.Internal reference (b)(4).

• Brand Name: INNOSPIRE ELEGANCE
• Common Device Name: 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
• MDR Report Key: 6390703
• Report Number: 9681154-2017-00004
• Device Sequence Number: 310229
• Product Code: CAF
• UDI-Device Identifier: 00383730003160
• UDI-Public: 00383730003160
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/20/2017

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
• Operator of Device: Other
• Device Model Number: 1095059
• Device Catalogue Number: 1104624
• Device Lot Number: 131210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1