MAUDE Adverse Event Report: RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. INSPRIATION ELITE; COMPRESSOR, AIR, PORTABLE

Model Number HS458

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2014

Event Type  malfunction  

Event Description

The manufacturer received information alleging a inspiration elite compressor had exposed wiring on the power cord of the device.Based on the information reported, there was no incident, no injury or death during this event.(b)(4).

Manufacturer Narrative

Device was not returned and the manufacturer is unable to determine the condition of the insulation.There was no patient harm or death reported in this instance.With the information provided, this investigation remains inconclusive.No further follow-up reporting will be provided for this complaint unless new information is made available to the manufacturer.

• Brand Name: INSPRIATION ELITE
• 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 ; UK
• Manufacturer Contact: alessandro agosti ; chichester business park; city fields way, tangmere; chichester, west sussex ; UK ; 704231549
• MDR Report Key: 4066627
• MDR Text Key: 4733844
• Report Number: 9681154-2014-00023
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K924123
• 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: 07/22/2014

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: HS458
• Device Catalogue Number: HS458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1