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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMP SYSTEM UK

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COVIDIEN SCD EXPRESS COMP SYSTEM UK Back to Search Results
Model Number 95251
Device Problems Break (1069); Electrical /Electronic Property Problem (1198)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
An investigation of product scd express compression system for the reported condition was performed.A review of the information in the complaint file indicates this investigation was performed by a covidien service center for the reported condition of; damaged power cord.Therefore, this report will be based on information provided by the service center.The unit was triaged and the complaint was confirmed; power cord was damaged with exposed copper wire (no patient harm).The root cause of the failure can be attributed to rough handling of the unit.The power cord was replaced to correct the problem.During triage, the technician also found that the unit's front case was damaged; front case was replaced.The unit was then fully tested; unit passed all testing.Product scd express compress system was manufactured in 2007.A review of the device history record shows this device was released meeting all manufacturing specifications.
 
Event Description
It was reported to covidien on (b)(6) 2015 customer states that the power cord is damaged.On 08/25/2015 covidien received notification and a photo from the service center that copper wire was exposed.
 
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Brand Name
SCD EXPRESS COMP SYSTEM UK
Type of Device
SCD EXPRESS
Manufacturer (Section D)
COVIDIEN
2824 airwest boulevard
plainfield IN 46168
Manufacturer (Section G)
COVIDIEN
2824 airwest boulevard
plainfield IN 46168
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield 02048
5084524811
MDR Report Key5088437
MDR Text Key26482985
Report Number3008361498-2015-00010
Device Sequence Number1
Product Code JOW
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Report Date 08/25/2015
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 Number95251
Device Catalogue Number95251
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/18/2015
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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