MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMP SYSTEM UK; SCD PUMP

Model Number 95251

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

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

A review of information in the complaint file indicates this investigation was performed by a covidien international service center for the reported condition of; case is broken.Therefore, this report will be based on information provided by the service center.Pictures contained in the complaint file show the power cord is damaged and shows external signs of burning near the end of the strain relief where it plugs into the unit, confirming a defect other than the reported condition.The root cause of failure can be attributed to excessive strain placed on the power cord near the strain relief while it was installed in the unit, which caused the internal wires to break and eventually short.Over time, normal flexing, wrapping the cord too tightly around the bed hook, or supporting the weight of the unit with the cord can cause individual wire strands to break which increases the amount of heat generated by current flow.The continued damage to the cord results in internally broken wires which increases the power cord's resistance, resulting in melting of the wire insulation and potential catastrophic failure.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.Product scd express compression system was manufactured in 2006.This information will be utilized for trending purposes to determine the need for corrective action.

Event Description

The customer reports a non-specific issue.The unit was sent to a covidien service center.Upon triage, a service technician found the power cord was cut near the connection to the scd unit exposing copper unit.

Manufacturer Narrative

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

• Brand Name: SCD EXPRESS COMP SYSTEM UK
• Type of Device: SCD PUMP
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: natasha soares ; 15 hampshire street; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4115890
• MDR Text Key: 19590567
• Report Number: 1717344-2014-00609
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/17/2014

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?: Yes
• Device Operator: Other
• Device Model Number: 95251
• Device Catalogue Number: 95251
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2014
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 07/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2014
• 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