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

Model Number 29525

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

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

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/13/2015.An investigation is currently underway.Upon completion, an updated investigation will be sent.

Event Description

It was reported to covidien on (b)(6) 2015 the customer stated the unit had a damaged power cord.Upon triage on (b)(6) 2015 the service tech found the unit had a damaged power cord with exposed copper wires.The unit was sent to the failure investigations department.

Manufacturer Narrative

Submit date: (b)(4) 2015.A review of the information in the complaint file indicates this investigation was performed by a medtronic/covidien technical center for the reported condition of; damaged power cord.Therefore, this report will be based on information provided by the service center.The unit was triaged and the complaint was confirmed; power cord was found damaged with exposed copper wires.The root cause of the reported condition can be attributed to rough handling of the unit.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.The unit was then fully tested; unit passed all tested.Scd compression system was manufactured in 2013.A review of the device history record shows this device was released meeting all manufacturing specifications.

• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5148404
• MDR Text Key: 28644059
• Report Number: 3006451981-2015-00224
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• 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
• Date Manufacturer Received: 09/15/2015
• 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