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

Model Number 1099969

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2015

Event Type  malfunction  

Event Description

(b)(4).The manufacturer received information alleging that a compressor "would not start".On return of the device it was noticed that exposed mains wiring was visible.The evaluation concluded that the device may have been damaged by the end user, as the strain relief of the power cord appeared to be damaged through excessive force/abuse which caused the exposed wiring.There is no allegation of any patient harm, and the device is not life supporting or life sustaining.

• 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, PO202 FT; UK PO202FT
• Manufacturer Contact: alessandro agosti ; chichester business park city; tangmere; chichester, PO202-FT ; UK PO202FT ; 8704231549
• MDR Report Key: 5250955
• MDR Text Key: 32157774
• Report Number: 9681154-2015-00020
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1099969
• Device Catalogue Number: 1099969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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