BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GB SCD EXPRESS COMP SYSTEM X1

    MDR report key: 4143599 · Received October 6, 2014

    Report

    Report Number
    3006451981-2014-00745
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SCD EXPRESS COMPRESSION SYSTEM WAS RETURNED TO AN INTERNATIONAL SERVICE CENTER FOR THE REPORTED CONDITION OF; POWER CORD EXPOSED DUE TO BEING CUT BY THE BEDSIDE HANDLES. THE INTERNATIONAL SERVICE NOTES INDICATE THAT THE POWER CORD IS CUT, CONFIRMING THE REPORTED CONDITION. THE INNER INSULATION WAS NOT EXPOSED SO THIS DID NOT POSE AN ELECTRICAL SAFETY HAZARD TO THE USER OR CLINICAL STAFF. THE ROOT CAUSE CAN BE ATTRIBUTED TO ROUGH HANDLING. POWER CORDS PERIODICALLY REQUIRE REPLACEMENT DUE TO AGE, USAGE AND USER DAMAGE. THE SERVICE MANUAL INSTRUCTS THE USER TO PERIODICALLY INSPECT THE POWER CORDS RESISTANCE TO ENSURE ITS ELECTRICAL SAFETY. THE POWER CORD NEEDS TO BE REPLACED TO CORRECT THE PROBLEM. PRODUCT SCD EXPRESS WAS MANUFACTURED IN 2011. ALL DEVICE HISTORY RECORDS ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR SHIPMENT. A REVIEW OF THE SERVICE HISTORY RECORDS INDICATES THERE ARE NO SERVICE HISTORIES RECORDED FOR THIS SYSTEM. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTION.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/06/2014.AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT THE CUSTOMER HAD A POWER CORD EXPOSED DUE TO BEING CUT BY THE BEDSIDE HANDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624882 GB SCD EXPRESS COMP SYSTEM X1 SCD CONTROLLER JOW COVIDIEN 95251S

    Patients

    Seq Age Sex Outcome Treatment
    1