MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSION SYSTEM-US; SCD CONTROLLER

Model Number 29525

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer issue with an scd controller.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 wires.

Manufacturer Narrative

An investigation is currently underway.An updated investigation will be provided upon completion.

Manufacturer Narrative

An investigation of the reported condition was performed on (b)(6) 2015 by (b)(6).One scd 700 was returned for investigation for the reported condition of; the unit had a damaged screen.The unit was returned to a local covidien service center and a service technician found that power cord was cut down to the bare wires.An initial inspection of the power cord found it failed to meet operational specifications due to an external damage, which cut through to the inner wires, exposing them, confirming the reported condition.The root cause of the power cord damage 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 700 was manufactured in 2014.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 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 700 COMPRESSION SYSTEM-US
• 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 ; 5084524644
• MDR Report Key: 4609709
• MDR Text Key: 5631143
• Report Number: 3006451981-2015-00066
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

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: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• 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