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

Model Number 1095060

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

Our evaluation of the device could find no fault other than that caused by the thermal event.The resistance readings of the device motor were in specification, and when we swapped the damaged mains lead out with a known good one, the device functioned normally and within specification.The extension lead that was returned with the device was not originally supplied with it - the ifu for this device states 'do not use any adapter, simple or multiple, and/or extension cord.' there were no markings on the extension lead to indicate conformance to any recognised standard.What appeared to be the plug prongs of another device were trapped in one of the other sockets of the extension lead.

Event Description

It was initially reported that the patient plugged the unit into an extension cord and the power cord and the extension cord melted together.On return of the device and the extension lead for evaluation, damage was observed that was consistent with a thermal event having occurred between the plug and the extension socket.It was also observed that the prongs of the plug had detached from the plug and had remained in one of the sockets of the extension lead, potentially creating a risk of electrocution.Internal reference:- (b)(4).

• Brand Name: INNOSPIRE ESSENCE
• 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: 5808780
• MDR Text Key: 49986870
• Report Number: 9681154-2016-00011
• Device Sequence Number: 1
• Product Code: CAF
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2016

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: 1095060
• Device Catalogue Number: 1100312
• Device Lot Number: 150316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2015
• 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