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

Model Number 95257

Device Problems Break (1069); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 08/28/2015.One scd controller compression system was returned for a damaged power cord.Upon triage at a local service center it was noticed there were exposed copper wires on the power cord.Initial inspection of the power cord showed it failed to meet operational specifications because it was externally damaged, exposing the internal copper wires which presented an electrical shock hazard, confirming there was an issue with the power cord.The root cause of the power cord failure can be attributed to rough handling.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 was replaced to correct the problem.The scd controller was fully tested and passed all operational specifications.The scd controller was manufactured in 2007.A review of the device history records shows this device was released meeting all manufacturing specifications.

Event Description

The customer stated the controller had a damaged power cord.No patient involvement.The extent of the issue with the power cord was unknown to covidien at the time the customer reported the issue.The scd controller was sent to a covidien service center and on upon triage the service technician noted that there was damage to the power cord that consisted of exposed copper wires.

• Brand Name: SCD EXPRESS COMP SYSTEM JAPAN
• Type of Device: SCD CONTROLLER
• 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, MA 02048 ; 5084524811
• MDR Report Key: 5040465
• MDR Text Key: 25219566
• Report Number: 3008361498-2015-00008
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 95257
• Device Catalogue Number: 95257
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2015
• 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