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

Model Number RDD490

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2016

Event Type  malfunction  

Event Description

The manufacturer received a complaint that when the patient tried pulling the power cord out of the wall outlet, the two prongs were stuck in the wall.Neither the device nor the power adapter has been returned for evaluation.As the broken adapter was not returned, the manufacturer is unable to confirm the complaint, but there is a possibility that the prongs of the plug of the power adapter 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.The device is not life-supporting or life-sustaining, and is no longer in production.(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: 6016857
• MDR Text Key: 57007697
• Report Number: 9681154-2016-00015
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063103
• 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: 09/21/2016

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: RDD490
• Device Catalogue Number: RDD490
• Device Lot Number: 083
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2008
• 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