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

Model Number 95251

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

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

Event Date 07/22/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with an scd controller.The plug of the power cord was burnt out and the fuse is completely charred.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

A review of information in the complaint file indicates this investigation was performed by a covidien international service center for the reported condition of; the power cable is burned.Therefore, this report will be based on pictures and information provided by the service center.Pictures in the report show damage to the area of the power cord where input power to the unit at the wall outlet shorted, emitting soot around the input ac pins, confirming the reported condition and identifying the root cause of failure.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.Product scd express was manufactured in 2007.The device history record was reviewed and all parameters and acceptance criteria were within specified limits when released.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: SCD EXPRESS COMP SYSTEM UK
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4214509
• MDR Text Key: 4999589
• Report Number: 1717344-2014-00818
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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