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

Model Number	1095059
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device had exposed wires.The device has not yet been returned for evaluation so we are unable to confirm any fault.However, based on the reported complaint, the patient may have been exposed to the risk of electrocution.The ifu for this 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)'.No patient harm or death has been reported and the device is not life sustaining/supporting.(b)(4).

• Brand Name: INNOSPIRE ELEGANCE
• Common Device Name: COMPRESSOR, AIR, PORATBLE
• 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: 6743422
• Report Number: 9681154-2017-00016
• Device Sequence Number: 11074241
• Product Code: CAF
• UDI-Device Identifier: 00383730001630
• UDI-Public: 00383730001630
• Combination Product (Y/N): N
• PMA/510(K) Number: K042655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/30/2017

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: 1100134
• Device Lot Number: 140721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1