BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 1800119 · Received August 10, 2010

    Report

    Report Number
    2242352-2010-02375
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: MAQUET CARDIOVASCULAR RECEIVED THE DEVICE FOR INVESTIGATION ON (B)(4), 2010. A VISUAL INSPECTION REVEALED THAT THE SILICON ON THE BACK OF THE COLD AND NOT JAWS WAS PEELING, THE HOT JAW WAS CHARRED, AND THE COLD JAW WAS VERY BURNT. THERE WAS SOME EVIDENCE OF BLOOD ON THE DEVICE. RESISTANCE MEASUREMENTS WERE NOT WITHIN SPECIFICATIONS. A PRE-CAUTERY TEST WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE DID NOT PERFORM ACCORDING TO SPECIFICATIONS WHERE DURING SEVERAL DEVICE ACTIVATIONS IT WOULD NOT ACTIVATE. BASED UPON THE FUNCTIONAL TEST, THE REPORTED COMPLAINT "WOULD NOT CONTINUALLY ACTIVATE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE. THIS LOT WAS MANUFACTURED PRIOR TO SEVERAL CORRECTIVE ACTIONS PUT INTO PLACE FOR THIS TYPE OF FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SURGEON HAD TO HOLD THE GREEN CORD THROUGHOUT THE PROCEDURE IN ORDER TO KEEP THE POWER ON THE VH-3000 ACTIVATED. THE SURGEON COMPLETED THE PROCEDURE USING THE REPORTED UNIT. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO HEMOPRO TISSUE WELDER GEI MAQUET CARDIOVASCULAR VH-3000 25004551

    Patients

    Seq Age Sex Outcome Treatment
    1 NA