BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOM ARTIS DTC

    MDR report key: 2398338 · Received December 29, 2011

    Report

    Report Number
    2240869-2011-00051
    Event Type
    Death
    Date Received
    December 29, 2011
    Date of Event
    November 29, 2011
    Report Date
    November 30, 2011
    Manufacturer
    SIEMENS AG
    Product Code
    IZI
    PMA / PMN Number
    K010721
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION APPEARS TO BE A RESULT OF A HARD DRIVE CRASH IN THE RADIOGRAPHIC IMAGING COMPUTER (BSR). FURTHER TROUBLESHOOTING SHOWED THAT THE PLUGS ON THE POWER CONNECTIONS OF THE UPS (UNINTERRUPTIBLE POWER SUPPLY) WERE CROOKED IN THE RECEPTACLES CAUSING THE UPS TO BE NON-FUNCTIONING. THE MALFUNCTIONING HARD DRIVE IN THE COMPUTER WAS REPLACED, AND THE SYS WAS BROUGHT BACK TO OPERATING CONDITION. THE BSR WAS RETURNED TO THE FACTORY IN (B)(4) FOR INVESTIGATION. THE CUSTOMER LATER SAID THAT "RISK MGMT AND BIOMED BOTH CLEARED THE EQUIPMENT AS NOT CAUSING THE DEATH."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EMERGENCY HEART CATHETERIZATION, THE DR WAS REVIEWING THE IMAGES WHEN THE MONITOR WENT BLANK. HE WAS UNABLE TO SEE THE FLUOROSCOPIC IMAGE AFTER THE MALFUNCTION. THE PT LATER EXPIRED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS DTC SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS AG 7413078 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death