BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 5162930 · Received October 20, 2015

    Report

    Report Number
    2242352-2015-01192
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 23, 2015
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    OCTOBER 19, 2015 10:28 AM (GMT-4:00) ADDED BY (B)(6): THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW 7 BISECTOR WOULD NOT WORK. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691380 VASOVIEW 7 XB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25108443

    Patients

    Seq Age Sex Outcome Treatment
    1