BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19182721 · Received April 25, 2024

    Report

    Report Number
    2242352-2024-00415
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Report Date
    June 12, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID#: (B)(4). NO LOT # WAS REPORTED AND NO SPECIFIC EVENT SITE WAS REPORTED, SO THEREFOR NO SHIP HISTORY WAS CONDUCTED.

    Additional Manufacturer Narrative · 0

    TW ID (B)(4) SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    TW # (B)(4). CORRECTED SECTION: H6- PROBLEM CODE CHANGED TO 2900.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    RECEIVED INCROWD SURVEY 27399-EVH PMS- JULY 2023, WHERE THEY COMMENTED "THE POWER CORD IS DIFFICULT TO REMOVE" WHEN ASKED ABOUT THE HARVESTING TOOL HEMOPRO 2 (VH-4000) EXTENSION CABLE CONNECTIONS INTERFACING WITH THE HARVESTING TOOL OR VV6 PRO HARVESTING CANNULA AND POWER SUPPLY OR GENERATOR ARE EASILY INSERTED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468300 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.