BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19183105 · Received April 25, 2024

    Report

    Report Number
    2242352-2024-00420
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Report Date
    May 22, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE (B)(4) CORRECTED SECTION: H6 PROBLEM CODE FROM "3189" TO "1310" NO LOT # WAS REPORTED AND NO SPECIFIC EVENT SITE WAS REPORTED, SO THEREFOR NO SHIP HISTORY WAS CONDUCTED. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM

    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. DEVICE NOT RETURNED.

    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 "IT OCCASIONALLY LOOSES INFLATION" WHEN ASKED ABOUT THE HARVESTING TOOL HEMOPRO 2 (VH-4000) THE BTT ACCESS PORT, SCOPE SEAL, AND MAIN SEAL ACCOMMODATE ALL NECESSARY INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162002 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown