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

Model Number 95251S

Device Problem Break (1069)

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

Event Date 10/26/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 2015 an investigation in currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

It was reported to covidien on (b)(6) 2015 that the customer initiated a service repair request regarding an scd controller.The unit was returned to a local covidien service center and upon triage found a live pin had broken off.

Manufacturer Narrative

(b)(4).A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; the live pin was broken off the plug.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 power cord was replaced to correct the problem.Scd express compression system was manufactured in 2008.A review of the device history record shows this device was released meeting all manufacturing specifications.

• 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: 5192831
• MDR Text Key: 30410882
• Report Number: 3006451981-2015-00261
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 95251S
• Device Catalogue Number: 95251S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2015
• 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