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

Model Number 95257

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/06/2015.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

On (b)(6) 2015 the customer initiated a service repair request regarding an issue with the power cord.The service tech found the unit had a damaged power cord with exposed copper wires.No patient involvement.

Manufacturer Narrative

A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; damaged power cord.Therefore, this report will be based on information provided by the technical center.The unit was triaged and the complaint was confirmed.The root cause of the power cord 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 was replaced to correct the problem.Scd express compression system was manufactured in 2007.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 JAPAN
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): PLAINFIELD; 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: 5207826
• MDR Text Key: 30880469
• Report Number: 3008361498-2015-00014
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2015
• 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