BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TW POWER SUPPLY, US

    MDR report key: 2508842 · Received March 27, 2012

    Report

    Report Number
    2242352-2012-00333
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO POWER SUPPLY STOPPED WORKING. THE SURGEON HAD TO OPEN THE LEG TO COMPLETE THE CASE. THEY DID NOT HAVE ANOTHER POWER SUPPLY TO USE. THE HOSPITAL 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other