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

Model Number 95251S

Device Problems Break (1069); Circuit Failure (1089); Sparking (2595)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that the customer reported a damaged power cord that sparked.The sample was returned to a local covidien service center and the service technician found that the power lead was cut and the live and neutral wires were shorting.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

A review of information in the complaint file indicates this investigation was performed by a covidien international service center for the reported condition of; customer reported damaged cable sparking.Therefore, this report will be based on information provided by the service center.Information provided in the complaint file states the power lead was cut and live and neutral were shorting; therefore, the reported condition is considered confirmed.There was no patient involvement, but the short of the live and neutral wires pose an electrical shock hazard.There was no failure analysis data provided in the complaint file; therefore, the root cause of failure was not identified.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 express was manufactured in 2005.The device history record was reviewed and all parameters and acceptance criteria were within specified limits when released.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: GB SCD EXPRESS COMP SYSTEM X1
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; 5920 longbow drive; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4154712
• MDR Text Key: 4930304
• Report Number: 1717344-2014-00888
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2014
• 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