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

Model Number 29525

Device Problems Break (1069); Cut In Material (2454); Scratched Material (3020)

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

Event Date 04/27/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 the customer reported that the unit had a damaged power cord.Upon triage on (b)(6) 2015 the service tech found the power cord was cut with exposed copper wires.

Manufacturer Narrative

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

Manufacturer Narrative

One scd controller compression system was returned for a damaged power cord.Upon triage at a local service center it was noticed there were exposed copper wires on the power cord.Initial inspection of the power cord showed it failed to meet operational specifications because it was externally damaged, exposing the internal copper wires which presented an electrical shock hazard, confirming the reported condition.The root cause of the power cord 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 was replaced to correct the problem.The scd controller was fully tested and passed all operational specifications.The scd controller was manufactured in 2013.A review of the device history records shows this device was released meeting all manufacturing specifications.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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4774122
• MDR Text Key: 5782817
• Report Number: 3006451981-2015-00118
• 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: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

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?: No
• Device Operator: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Device Lot Number: V1341672SX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2015
• Initial Date FDA Received: 05/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• 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