BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASO VIEW HEMOPRO

    MDR report key: 1022248 · Received March 26, 2008

    Report

    Report Number
    2953148-2008-00311
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Report Date
    March 6, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION WAS COMPLETED AND IT WAS OBSERVED THAT THE JAW BOOT WAS THERMALLY DAMAGED. THIS INDICATED THAT THE JAWS HAD EXPERIENCED ELEVATED TEMPERATURES AT ONE POINT IN TIME AND COULD HAVE BEEN A RESULT OF AN INTERMITTENT CIRCUIT FAILURE. THE REPORTED OBSERVATION WAS CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON CONFORMANCE REPORTS, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO WAS INITIALLY CONNECTED THE WIRE JAWS WERE RED AND HOT WITHOUT BEING ACTIVATED. THE HOSPITAL USED A SECOND HEMOPRO DEVICE, SUCCESSFULLY COMPLETED THE CASE. NO PT COMPLICATIONS WERE REPORTED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASO VIEW HEMOPRO GEI GUIDANT CARDIAC SURGERY VH-3000 7102371

    Patients

    Seq Age Sex Outcome Treatment
    1 NA