BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1873702 · Received September 21, 2010

    Report

    Report Number
    2242352-2010-02869
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6), 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THERE WERE NO NON-CONFORMITIES WITH THE DEVICE, NO SIGNS OF CLINICAL USAGE, AND MINIMAL EVIDENCE OF BLOOD. RESISTANCE MEASUREMENTS MET SPECS. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PERFORMED ACCORDING TO SPECS DURING SEVERAL DEVICE ACTIVATIONS, IT PRODUCED STEAM. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT FOR "WOULD NOT ACTIVATE" WAS NOT CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE RETURNED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM UNIT NEVER ACTIVATED. THERE WERE NO PT EFFECTS. THE CASE WAS COMPLETED USING ANOTHER VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3000 25014862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA