BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW POWER SUPPLY, US

    MDR report key: 2492743 · Received March 9, 2012

    Report

    Report Number
    2242352-2012-00283
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 6, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE OUTPUT ENERGY ON THE POWER SUPPLY COULD NOT BE VERIFIED. THE HOSP INTENDS TO RETURN THE PRODUCT IN QUESTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA