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

Model Number 9525

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

Event Description

The customer states that they needed an updated power cordon (b)(6) 2015.The unit was returned to a local covidien service center and a service technician found that the power cord was cut down to the bare cooper wire.

Manufacturer Narrative

An investigation is currently underway.Upon completion, an updated investigation will be provided.

Manufacturer Narrative

An investigation of the reported condition was performed on (b)(6) 2015 by (b)(6).One scd express compression system was returned for investigation for the reported condition of; the unit was returned to a local covidien service center and a service technician found that the power cord was cut down to the bare cooper wire.Initial inspection found the power cord showed it was externally damaged and had damaged the insulation on the internal wires exposing the copper conductors, confirming the reported condition.There was no signs of arcing to the exposed copper wiring indicating the unit was not connected to a live circuit.However, the exposed wires produce a high risk of electrical shock to the clinical staff and patient.The root cause of the damaged fan and power cord 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 was replaced to correct the problem.Product scd express was manufactured in 2008.A review of the device history records shows this device was released meeting all manufacturing specifications.A review of the service history records indicates there are no other service histories recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building #10, puxing road; shanghai ; CH
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4551531
• MDR Text Key: 5462099
• Report Number: 3006451981-2015-00058
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/16/2015

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 02/26/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• 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