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

Model Number 1063532

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2016

Event Type  malfunction  

Event Description

The manufacturer received information that the device failed to power on due to a broken power cord.It was reported that 'a terminal of ac adapter (ac inlet side) is broken and it cannot be used but the broken component was not attached.' these devices were originally supplied with a mains adapter with an interchangeable head - the interchageable head was not returned with the device for evaluation.As the broken component was not returned with the device the manufacturer is unable to confirm the complaint, but there is a possibility that a prong of the interchageable head broke off in a mains socket - if this was the case, then a risk of exposure to a live part would be created.The most likely explanation for any such concern would be that the plug would have been damaged by the end user applying excessive force.There is no report of any patient harm, and the device is not life-supporting or life-sustaining.(b)(4).

• Brand Name: MICROELITE COMPRESSOR
• 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: 5735403
• MDR Text Key: 47738732
• Report Number: 9681154-2016-00008
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1063532
• Device Catalogue Number: 1076955
• Device Lot Number: 11M-0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2011
• 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