BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOPRO2 EXTENSION CABLE

    MDR report key: 2180772 · Received April 29, 2011

    Report

    Report Number
    2242352-2011-00484
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 4, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INVESTIGATION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE CABLE. THE OUTPUT CURRENT READING OF THE RETURNED CABLE WITH A REFERENCE POWER SUPPLY WERE WITHIN SPECIFICATIONS. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND HEMOPRO TOOL. THE DEVICE PASSED PRE-CAUTERY TEST; THE HEMOPRO DEVICE PRODUCED ENERGY AND STEAM. BASED UPON THE FUNCTIONAL TEST, THE REPORTED FAILURE, ¿WOULD NOT ACTIVATE¿ COULD NOT BE CONFIRMED". (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-4000 WOULD NOT ACTIVATE. THIS OCCURRED DURING THE HP2 PRE-TEST WITH THE GENERATOR SETTING AT 3. A REPLACEMENT CABLE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMOPRO2 EXTENSION CABLE CABLE GEI MAQUET CARDIOVASCULAR, LLC. VH-4030 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA