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

Model Number	1095060
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power cord of this device was ripping and falling apart.On return of the device for evaluation, it was apparent that the insulation on the mains cord was degraded to the extent that bare wires were visible.Our evaluation concluded that in all likelihood the cord has been subjected to considerable external force.(b)(4).

• Brand Name: INNOSPIRE ESSENCE
• 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: 6629122
• Report Number: 9681154-2017-00008
• Device Sequence Number: 1048634
• Product Code: CAF
• UDI-Device Identifier: 00383730001814
• UDI-Public: 0383730001814
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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: Lay User/Patient
• Device Model Number: 1095060
• Device Catalogue Number: 1099966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1