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

Model Number 29525

Device Problems Break (1069); Thermal Decomposition of Device (1071)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

The customer states that during testing the power cable had cooper wires exposed, breaking and burns were confirmed.There were no patients involved.

Manufacturer Narrative

Submit date: 11/25/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

An investigation of the reported condition was performed on 1/14/2015 by (b)(6).A review of information in the complaint file indicates this investigation was performed by a covidien international service center for the reported condition of; the customer states that during testing the power cable had copper wires exposed, breaking and burns were confirmed.There were no patients involved.Therefore, this report will be based on information provided by the service center.The pictures provided in the complaint report shows the power cord was externally damaged and had damaged the insulation on the internal wires exposing the copper conductors which presented an electrical shock hazard, confirming the reported condition.The root cause of failure 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 700 compression system was manufactured in 2013.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.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; 789 puxing road; shanghai ; CH
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4275242
• MDR Text Key: 16086670
• Report Number: 3006451981-2014-00780
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2015
• 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