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

Model Number U9525

Device Problem Break (1069)

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

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/11/2016.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

On (b)(6) 2016 a specific issue was not identified on this back to stock unit.Upon triage on (b)(6) 2016 the service tech found the unit had a damaged power cord with exposed copper wires.

Manufacturer Narrative

Submit date: 02/19/2016.A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; an issue was not specified on this back to stock unit.During service a damaged power cord with exposed copper wire was found.Therefore, this report will be based on information provided by the technical center.The scd express was evaluated and the customer reported issue was confirmed; the power cord's outer and inner insulations were damaged allowing view of the inner copper wire.The cause of the reported condition for the damaged power cord was due to customer misuse.The power cord was scrapped and replaced to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd express was manufactured in 2011.A review of the device history record shows this device was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed.

• 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: 5430029
• MDR Text Key: 38668569
• Report Number: 3006451981-2016-00126
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2016
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2016
• 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