BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2192883 · Received July 25, 2011

    Report

    Report Number
    2242352-2011-00997
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 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
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE HEATER WAS DETACHED FROM THE JAW BOOT TIP AND WAS BENT. THE JAWS HAD SOME SIGNS OF CLINICAL USAGE. THERE WAS SOME EVIDENCE OF BLOOD. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECIFICATIONS. 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 SPECIFICATIONS DURING THE DEVICE ACTIVATION. BASED UPON THIS OBSERVATION, THE REPORTED COMPLAINT FOR "KEPT SHUTTING OFF" 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 UNIT KEPT SHUTTING OFF. THE UNIT WILL STOP WORKING AFTER A LARGE BRANCH IS DIVIDED AND THE OPERATOR WILL WAIT THE 15-30 SECONDS, BUT THE UNIT SHUTS OFF AFTER JUST A FEW SECONDS AND THE INTERVAL FROM ACTIVATION TO STOPPING INCREASINGLY GETS SHORTER AND SHORTER. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT 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 25036291

    Patients

    Seq Age Sex Outcome Treatment
    1 NA