MAUDE Adverse Event Report: COVIDIEN GB SCD EXPRESS COMP SYSTEM X1; SCD CONTROLLER

Model Number 95251S

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

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

Event Date 09/18/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that the customer had a power cord exposed due to being cut by the bedside handles.

Manufacturer Narrative

Submit date: 10/06/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

One scd express compression system was returned to an international service center for the reported condition of; power cord exposed due to being cut by the bedside handles.The international service notes indicate that the power cord is cut, confirming the reported condition.The inner insulation was not exposed so this did not pose an electrical safety hazard to the user or clinical staff.The root cause 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.Product scd express was manufactured in 2011.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.A review of the service history records indicates there are no service histories recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: GB SCD EXPRESS COMP SYSTEM X1
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building #10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4143599
• MDR Text Key: 4787981
• Report Number: 3006451981-2014-00745
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

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: 95251S
• Device Catalogue Number: 95251S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2014
• Initial Date FDA Received: 10/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• 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