MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS CONTROLLER; SCD CONTROLLER

Model Number U9525

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

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(4) 2015.Investigation findings: an investigation of product scd express controller for the reported condition was performed.A review of the information in the complaint file indicates this investigation was performed by a covidien/medtronic service center for the reported condition of; unit's fan runs while unit is off.Therefore, this report will be based on information provided by the service center.The unit was triaged and the complaint could not be duplicated; complaint not confirmed.During triage, the technician visually inspected the unit and found that the unit's power cord was damaged with exposed copper wire.The root cause of the damaged power cord can be attributed to rough handling.The power cord was replaced to correct the problem.Further visual inspection revealed that the units rear enclosure was damaged; rear enclosure was replaced.The unit was then fully tested; unit passed all testing.The unit passed all testing.Product scd express controller was manufactured in 2010.A review of the device history record shows this device was released meeting all manufacturing specifications.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with an scd controller.The customer states that the unit's fan runs while its off.The unit was returned to a local covidien service center and a service technician found during visual inspection that the unit's power cord was damaged with exposed copper wires.

• Brand Name: SCD EXPRESS CONTROLLER
• 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: 5086969
• MDR Text Key: 26489909
• Report Number: 3006451981-2015-00211
• 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: company representative,user f
• Reporter Occupation: Other
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: U9525
• Device Catalogue Number: U9525
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2015
• 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