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

Model Number 9525

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/13/2016.An investigation is currently underway.Upon completion, a full detailed report will be provided.

Event Description

On (b)(6) 2016 the customer states the unit is not running.Upon triage on (b)(6) 2016 the service tech found the unit had a damaged power cord with exposed copper wire.

Manufacturer Narrative

Submit date: 11/01/2016.A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; not running.During evaluation 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 exposed copper wire was visible on the power cord.The cause of the reported condition for the damaged power cord with exposed copper wires was due to misuse.The power cord was replaced to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd express was manufactured in 2012.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 COMPRESSION SYSTEM
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5945590
• MDR Text Key: 54885511
• Report Number: 3006451981-2016-00405
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9525
• Device Catalogue Number: 9525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/01/2016
• 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