BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMC-V GENERATOR ENGLISH

    MDR report key: 3551745 · Received January 3, 2014

    Report

    Report Number
    1226348-2014-10159
    Event Type
    Injury
    Date Received
    January 3, 2014
    Date of Event
    October 24, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    GEI
    PMA / PMN Number
    PK896541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE SUPPLIER EVALUATION REVEALED THE FOLLOWING: UNIT AS RECEIVED HAD AN ERROR CODE 13 STORED IN THE ERROR STACK. UNIT WAS SUBJECTED TO THE ENHANCED BURN IN PER KOP - 374. UNIT FAILED THE 12 HOUR BURN IN (UNIT RESETS) VIDEO BOARD NEEDS TO BE REPLACED POWER SUPPLY REQUIRES UPDATE PER DCR 9236. FIX: UPDATED POWER SUPPLY PER DCR 9236. REPLACED VIDEO BOARD TESTED PER QAK-009/4 TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGAITON A FOLLOW UP REPORT WILL BE FILED

    Description of Event or Problem · 1

    NO POWER OUTPUT FROM THE DEVICE CONNECTED TO THE CABLE (80-1791/SN:(B)(4)) WAS NOTED WHEN IT WAS USED AT THE SURGERY. WHEN THE DEVICE WAS ACTIVATED, THERE WAS ABNORMAL NOISE WITH THE RED LAMP BLINKING. AFTER THE POWER SWITCH WAS OFF AND ON, IT WORKED AS USUAL. HOWEVER, ON THE NEXT DAY OF THE SURGERY, THE SAME EVENT OCCURRED AGAIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AS OF TODAY, NO DELAY GREATER THAN 30MIN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3677 CMC-V GENERATOR ENGLISH DEVICE, ELECTROSURGICAL, CUTTING & COAG & ACC GEI CODMAN & SHURTLEFF, INC XL12071490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention