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

Model Number 95257

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, a full detailed report will be provided.

Event Description

The customer states that the power cable was found damaged during use on a patient.There was copper wire exposed.No patient harm.

Manufacturer Narrative

After initial review of the information in the complaint file, the complaint was confirmed.The power cord attached to scd express comp system (b)(4), was found to have its outer insulation damaged, allowing view of the inner copper wire.The customer stated the power cable got caught and damaged during use, therefore the cause of the reported condition was due to accidental damage during customer use.The damaged power cord will be scrapped and replaced to correct the reported issue.Scd express comp system (b)(4) was manufactured in 2014.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: 5708693
• MDR Text Key: 46888549
• Report Number: 3006451981-2016-00245
• 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: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• 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: 07/12/2016
• 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