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

Model Number	1095067
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device had a broken cover.On return of the device for evaluation it was observed that the mains cord was damaged to the extent that bare copper wires were exposed.The customer has been approached with a view to identifying how this damage occurred, but to date they have not provided any further information.Based on this, the patient may have been exposed to the risk of electrocution.The cover was not broken.(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, PO20 2FT; UK PO20 2FT
• MDR Report Key: 7572835
• Report Number: 9681154-2018-00010
• Device Sequence Number: 1698742
• Product Code: CAF
• UDI-Device Identifier: 00383730001715
• UDI-Public: 00383730001715
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 1095067
• Device Catalogue Number: 1099973
• Device Lot Number: 140627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1