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

Model Number 95257

Device Problems Break (1069); Malposition of Device (2616)

Patient Problem No Information (3190)

Event Date 05/11/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/17/2016.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

The customer states that the power cable was found damaged during testing.Upon triage on (b)(6), the service tech found that there was copper wire exposed.

Manufacturer Narrative

After initial review of the information in the complaint file, the complaint was confirmed.The power cord attached to scd express, was found to have its outer insulation damaged, allowing view of the inner copper wire.The cause of the reported condition for the damaged power cord was due to handling.The damaged power cord is to be replaced to correct the reported issue.Scd express was manufactured in 2011.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 COMP SYSTEM JAPAN
• 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: 5660928
• MDR Text Key: 46573926
• Report Number: 3006451981-2016-00222
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 95257
• Device Catalogue Number: 95257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• 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