BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW POWER SUPPLY, US

    MDR report key: 2201464 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01151
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TW POWER SUPPLY, US WAS INTERMITTENT. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. MAQUET CARDIOVASCULAR ANTICIPATES RETURN OF THE PRODUCT IN QUESTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA