BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 1993678 · Received January 6, 2011

    Report

    Report Number
    2242352-2010-03906
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 10, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE HEATER WAS DETACHED FROM THE TIP AND BENT. THERE WERE SOME SIGNS OF CLINICAL USAGE AND SOME EVIDENCE OF BLOOD ON THE DEVICE. 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. THE HANDLE WAS OPENED UP AND THE MICROSWITCH ARM WAS FOUND TO BE SOMEWHAT BENT. BASED UPON THE INVESTIGATION, THE REPORTED COMPLAINT FOR "WOULD NOT ACTIVATE" WAS 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 VEIN HARVESTING PROCEDURE, THE JAWS WOULD NOT ACTIVATE. 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 25014837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA