MAUDE Adverse Event Report: PLAINFIELD SCD EXPRESS COMPRESSION SYSTEM; SCD CONTROLLER

Model Number 9525

Device Problems Break (1069); Cut In Material (2454); Scratched Material (3020)

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

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/10/2016.A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; the unit is not working.During triage the unit was found to have a damaged power cord that was cut, burnt, and had exposed copper wire.Therefore, this report will be based on information provided by the technical center.The scd express was evaluated and the customer reported issue was confirmed; the unit's main board had solder shorts at u4 and the power cord's outer insulation was damaged, allowing view of the inner copper wire.The cause of the reported condition for the damaged power cord and the unit not working was due to customer misuse.The unit's main board and power cord were scrapped and replaced to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd express 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.

Event Description

On (b)(6) 2016 the customer states the unit is not working.Upon triage on (b)(6) 2016, factory service found the unit had a damaged power cord with cut/burn marks and exposed copper wire.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): PLAINFIELD; 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: 5497579
• MDR Text Key: 40547142
• Report Number: 3008361498-2016-00008
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/04/2016

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: 9525
• Device Catalogue Number: 9525
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 03/14/2016
• 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