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

Model Number 95251S

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/04/2016.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

The customer reported broken plug.Upon triage the technician verified reported issue as a live pin had snapped off of the plug the power cord did not have any exposed copper wires.

Manufacturer Narrative

Submit date: (b)(6) 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; damaged live pin.Therefore, this report will be based on information provided by the technical center.The unit was triaged and the complaint was confirmed.The root cause of the power cord failure can be attributed to rough handling of the unit.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.Scd express compression system was manufactured in 2010.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): 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: 5340962
• MDR Text Key: 35293036
• Report Number: 3006451981-2016-00003
• 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,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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
• Device Lot Number: SN1001558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• 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