MAUDE Adverse Event Report: COVIDIEN GB SCD EXPRESS COMP SYSTEM X1; SCD CONTROLLER

Model Number 95251S

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 08/10/2015

Event Type  malfunction  

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 2009.A review of the device history records shows this device was released meeting all manufacturing specifications.

Event Description

The customer returned a scd controller to a covidien service center for a damaged power cord with exposed copper wires.

• Brand Name: GB SCD EXPRESS COMP SYSTEM X1
• 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: 5073411
• MDR Text Key: 26084139
• Report Number: 3006451981-2015-00207
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 95251S
• Device Catalogue Number: 95251S
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2009
• 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