MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSION SYSTEM-US; SCD CONTROLLER

Model Number 29525

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

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/16/2016.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

On (b)(6) 2016 the customer initiated a service repair request for an unknown issue.Upon triage on (b)(6) 2016 the service tech found the unit had a cut power cord with burns/thermal damage (with exposed copper wire).

Manufacturer Narrative

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 unknown by the customer.During triage the power cord was found to have a cut with burns.Therefore, this report will be based on information provided by the technical center.The scd 700 was evaluated and the customer reported issue was confirmed; the power cord had visible damage with an internal burn.The cause of the reported condition for the damaged power cord was due to customer misuse.The power cord was removed and replaced to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd 700 was manufactured in 2013.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 700 COMPRESSION SYSTEM-US
• 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: 5503770
• MDR Text Key: 40421082
• Report Number: 3006451981-2016-00156
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2016
• 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