MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSION SYSTEM-US; SCD CONTROLLER

Model Number 29525

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that customer had an issue with an scd controller.The customer states that during testing the power code was found broken and cooper wiring was exposed.No pt involvement.

Manufacturer Narrative

Submit date: 08/18/2014.A review of information in the complaint file indicates this investigation was performed by a covidien international service center.Therefore, this report will b e based on information provided by the service center.A picture provided in the complaint report shows the power cord failed to meet operations specifications due to an external damage, which cut through to the inner copper wires, exposing them, confirming the reported condition.There was no signs of arcing to the exposed copper wiring indicating the unit was not connected to live circuit.However, the exposed wires produce a high risk of electrical shock to the clinical staff and pt.The root cause of the power cord damage 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 needs to be replaced to correct the problem.The unit was then fully tested and found to function normally and within specifications.Product scd 700 was manufactured in 2011.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.The customer has reported no other complaints for the same condition in the last twelve months.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: SCD 700 COMPRESSION SYSTEM-US
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; buliding #10, 789 puxing; shanghai ; CH
• Manufacturer (Section G): SHANGHAI; building 10 789 puxing road; shanghai ; CH
• Manufacturer Contact: natasha soares ; 15 hampshire street; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4218718
• MDR Text Key: 5002078
• Report Number: 3006451981-2014-00710
• 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: User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/30/2014

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: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/18/2014
• Initial Date FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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