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 06/22/2017

Event Type  malfunction  

Event Description

It was reported that the prongs on the plug of this device remained in the mains socket when the patient tried to unplug it.On return of the device for evaluation, it was confirmed that both prongs were missing from the plug.It would therefore appear that a risk of electrocution may have been created by having metal prongs protruding from a live mains socket.(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: 6705126
• MDR Text Key: 79758876
• Report Number: 9681154-2017-00013
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00383730001630
• UDI-Public: 00383730001630
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: 1095059
• Device Catalogue Number: 1100134
• Device Lot Number: 151209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1