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

Model Number 9525

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

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

Event Date 03/24/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

On (b)(6) 2016 the customer initiated a service repair request regarding a specific issue not stated.Upon triage on 3/24/2016 the service tech found the unit had a damaged power cord with exposed copper wires.

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; a damaged power cord with exposed copper wire found during service.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 power cord was found to have a cut in the outer insulation, exposing the copper wiring on the internal white and green wires.The power cord was scrapped to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd express was manufactured in 2006.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 COMPRESSION SYSTEM
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; 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: 5528694
• MDR Text Key: 41541769
• Report Number: 3008361498-2016-00009
• 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
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• 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