BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2180695 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00822
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE JAWS HAD NO NON CONFORMITIES AND SOME SIGNS OF CLINICAL USAGE. THERE WAS SOME EVIDENCE OF BLOOD. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND CABLE. THE DEVICE PERFORMED ACCORDING TO SPECS DURING THE DEVICE ACTIVATION. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "INTERMITTENT POWER" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 DID NOT WORK, "THE USER WAITED 4 X 30 SEC FOR IT TO RESET BUT IT STILL NEVER WORKED CORRECTLY, ALSO, IT SPARKED WHEN IT WAS TESTED WITH A WET LAP, BUT THE USER DECIDED TO USE IT ANYWAY." THE REPORTER CLARIFIED THAT THE DEVICE HAD ONLY BEEN USED MINIMALLY, AND IT KEPT SHUTTING DOWN. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25035991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA