MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMP SYSTEM UK; SCD CONTROLLER

Model Number 95251

Device Problems Thermal Decomposition of Device (1071); Cut In Material (2454); Sparking (2595)

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

Event Date 11/02/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion a full detailed investigation will be provided.

Event Description

It was reported to covidien that the customer states that during use the unit sparked.The unit was returned to a local covidien service center.Upon triage a service technician found a small cut at power cord with some burnt marks most likely caused by the sparking.

Manufacturer Narrative

One scd express was returned for investigation for the reported condition of; customer states: that during use the unit sparked.The unit was returned to a local covidien service center.Upon triage a service technician found a small cut at power cord with some burnt marks most likely caused by the sparking.The unit was also received with damage to the case.The unit was inspected and the power cord was found to have signs of arcing where it plugs into the base of the unit, confirming the reported condition.The root cause of failure can be attributed to rough handling of the unit.Power cords periodically require replacement due to age, usage and user damage.The service manual instructs the user to periodically inspect the power cords resistance to ensure its electrical safety.The power cord needs to be replaced to correct the problem.Scd express compression system was manufactured in 2010.A review of the device history record shows this device was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed.

• Brand Name: SCD EXPRESS COMP SYSTEM UK
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5220017
• MDR Text Key: 31230274
• Report Number: 3008361498-2015-00015
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 11/12/2015

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: No Information
• Device Model Number: 95251
• Device Catalogue Number: 95251
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2016
• 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