BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMC-V GENERATOR

    MDR report key: 4192287 · Received October 22, 2014

    Report

    Report Number
    1226348-2014-12062
    Event Type
    Injury
    Date Received
    October 22, 2014
    Manufacturer
    SYNERGETICS
    Product Code
    GEI
    PMA / PMN Number
    PK050364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT UPON A PERFORMANCE EVALUATION THAT WE WERE UNABLE TO DUPLICATE THE COMPLAINT MADE BY THE CUSTOMER. THE UNIT WAS RECEIVED AS FULLY OPERATIONAL AND MET ALL FACTORY SPECIFICATIONS. THE UNIT WAS TESTED FOR 4 HOURS, OBSERVED TO OPERATE WITHOUT FAILURE, AND PASSED THE FINAL ACCEPTANCE TEST. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    REP CALLED AND REPORTED THAT BIOMED UNPACKED A BRAND NEW UNIT AND CONDUCTED INITIAL TESTING THAT INDICATED THAT THE OUTPUT WAS NOT MATCHING WITH THE TEST RESULTS. HOSPITAL TECH SUPPORT CONFIRMED THAT IT WAS A BAD UNIT. DEVICE WAS NOT USED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673863 CMC-V GENERATOR ELECTROSURGICAL GENERATOR GEI SYNERGETICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention