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

Model Number HS456

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2015

Event Type  malfunction  

Event Description

(b)(4).The manufacturer received information alleging the air outlet of a compressor was damaged.There was no allegation of exposed wiring at the time of reporting.The unit was returned to our facility and during the evaluation the power cord was observed to have exposed wires.The evaluation concluded that very likely the device had been inadvertently damaged by the end user, as the power cord appeared to be damaged through excessive force/abuse which caused exposed wiring.The user manual for this device states "never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged or dropped into water.Return the product to a service center for examination and repair." this device is not life sustaining or life supporting.There was no reported harm or injury alleged to the patient.Device manufacture date is march 2012.

• Brand Name: INSPIRATION ELITE
• 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: 5232024
• MDR Text Key: 31449387
• Report Number: 9681154-2015-00017
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: HS456
• Device Catalogue Number: HS458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Date Manufacturer Received: 10/23/2015
• 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