MAUDE Adverse Event Report: COVIDIEN LP SCD EXPRESS COMPRESSION SYSTEM; SCD PUMP

Model Number 9525

Device Problem Cut In Material (2454)

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

Event Type  malfunction  

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 through the outer jacket, exposing copper wire inside inner insulation.

Manufacturer Narrative

Submit date: (b)(4) 2014.One scd express compression system was returned for investigation for the reported condition of; power cord is showing copper wires.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 was fully tested and passed all operational specifications the scd express was manufactured in 2007.The device history record was reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Type of Device: SCD PUMP
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow dr.; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 4012103
• MDR Text Key: 15322217
• Report Number: 1717344-2014-00579
• 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
• Report Date: 06/18/2014

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: 9525
• Device Catalogue Number: 9525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• 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