BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW TISSUE WELDER POWER SUPPLY, US

    MDR report key: 1626405 · Received February 12, 2010

    Report

    Report Number
    2242352-2010-00311
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 15, 2010
    Report Date
    January 15, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO CARDIAC SURGERY ON (B) (6) 2010 FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. (B) (4)

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-3010 POWER SUPPLY WOULD NOT WORK; THE LED LIGHT WOULD NOT TURN ON. THE HOSPITAL TRIED SWITCHING THE HEMOPRO CABLE, BUT IT DID NOT WORK. THEY THEN TRIED REPLACING THE POWER SUPPLY POWER CORD WITH TWO CORDS THEY HAD, AND IT STILL DID NOT WORK. THEY COMPLETED THE PROCEDURE USING A REPLACEMENT UNIT. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE UNIT THAT INITIALLY MALFUNCTIONED IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW TISSUE WELDER POWER SUPPLY, US TW POWER SUPPLY, US HQO MAQUET CARDIOVASCULAR, LLC. VH-3010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA