MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMP SYSTEM UK

Model Number 95251

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An investigation of product scd express compression system for the reported condition was performed.A review of the information in the complaint file indicates this investigation was performed by a covidien service center for the reported condition of; damaged power cord.Therefore, this report will be based on information provided by the service center.The unit was triaged and the complaint was confirmed; power cord was damaged with exposed copper wire (no patient harm).The root cause of the failure can be attributed to rough handling of the unit.The power cord was replaced to correct the problem.During triage, the technician also found that the unit's front case was damaged; front case was replaced.The unit was then fully tested; unit passed all testing.Product scd express compress system was manufactured in 2007.A review of the device history record shows this device was released meeting all manufacturing specifications.

Event Description

It was reported to covidien on (b)(6) 2015 customer states that the power cord is damaged.On 08/25/2015 covidien received notification and a photo from the service center that copper wire was exposed.

• Brand Name: SCD EXPRESS COMP SYSTEM UK
• Type of Device: SCD EXPRESS
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield 02048 ; 5084524811
• MDR Report Key: 5088437
• MDR Text Key: 26482985
• Report Number: 3008361498-2015-00010
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 95251
• Device Catalogue Number: 95251
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2015
• 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