MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSIO NSYSTEM; SCD PUMP

Model Number 29525

Device Problem Break (1069)

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 is damaged exposing copper wires and is an electrical safety hazard.

Manufacturer Narrative

One scd 700 was returned for investigation for the reported condition of; service found exposed wires.An initial inspection of the power cord found it failed to meet operational specifications due to an external damage, which cut through the inner copper wires, exposing them, confirming the reported condition.There was no signs of arcing to the exposed copper wiring indicating the unit was not connected to live circuit.However, the exposed wires produced a high risk of electrical shock to the clinical staff and patient.The root cause of the power cord damage 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 unit was then fully tested and found to function normally and within specifications.Product scd 700 was manufactured in 2013.All device history records (dhr) are reviewed fo quality inspections and parameter compliance prior to releasing the product for shipment.A review of the service history records indicates there are no other service histories recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: SCD 700 COMPRESSIO NSYSTEM
• Type of Device: SCD PUMP
• Manufacturer (Section D): COVIDIEN; building 10 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4012102
• MDR Text Key: 14879172
• Report Number: 3006451981-2014-00676
• 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: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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