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U.S. Department of Health and Human Services

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

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COVIDIEN SCD EXPRESS COMP SYSTEM JAPAN; SCD CONTROLLER Back to Search Results
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.
 
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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 Key5660928
MDR Text Key46573926
Report Number3006451981-2016-00222
Device Sequence Number1
Product Code JOW
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number95257
Device Catalogue Number95257
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/17/2016
Initial Date FDA Received05/17/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/09/2016
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 Number1
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