BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TW POWER SUPPLY, US

    MDR report key: 2480655 · Received February 22, 2012

    Report

    Report Number
    2242352-2012-00209
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Report Date
    February 17, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    HQO
    PMA / PMN Number
    K043155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO POWER SUPPLY WOULD NOT POWER UP. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. 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