MAUDE Adverse Event Report: SHANGHAI GB SCD EXPRESS COMP SYSTEM X1; SCD CONTROLLER

Model Number 95251S

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The unit was received for service and upon triage the service technician found that the unit had a damaged power cord with exposed copper wires.

Manufacturer Narrative

Submit date: 03/01/2016.A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; a damaged power cord with exposed copper wires.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 insulation was 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 replaced to correct the reported issue.The unit passed all initial testing after repairs were completed.Scd express was manufactured in 2009.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: GB SCD EXPRESS COMP SYSTEM X1
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): SHANGHAI; 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: 5404479
• MDR Text Key: 37661050
• Report Number: 3006451981-2016-00110
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 95251S
• Device Catalogue Number: 95251S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2016
• 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