BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT TW POWER SUPPLY, US

    MDR report key: 1051600 · Received May 19, 2008

    Report

    Report Number
    2953148-2008-00531
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO POWER SUPPLY WOULD NOT GIVE POWER. A REPLACEMENT POWER SUPPLY WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT TW POWER SUPPLY, US GEI GUIDANT CARDIAC SURGERY VH-3010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA