BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DC EXTENSION CABLE

    MDR report key: 4173337 · Received October 10, 2014

    Report

    Report Number
    2242352-2014-01100
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DC EXTENSION CABLE WAS NOT WORKING WHEN IT WAS PLUGGED IN. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643306 DC EXTENSION CABLE ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3030

    Patients

    Seq Age Sex Outcome Treatment
    1