BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCADIS AVANTIC

    MDR report key: 2142698 · Received June 17, 2011

    Report

    Report Number
    2240869-2011-00020
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    SIEMENS AG
    Product Code
    IZL
    PMA / PMN Number
    K051133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY SIEMENS AREA SERVICE MANAGER, (B)(6), THAT REPAIR WORK WAS PERFORMED AT THE SITE (B)(4) 2011. NEW COMPUTER WAS INSTALLED, THE SOFTWARE WAS RELOADED, AND THE PARTS WERE SENT TO THE FACTORY FOR FURTHER INVESTIGATION. THE SYSTEM HAS BEEN FUNCTIONING WITHIN SPECIFICATIONS SINCE (B)(4) 2011. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARCADIS AVANTIC HAS BEEN INTERMITTENTLY SHUTTING DOWN DURING SURGICAL PROCEDURES LEAVING PHYSICIANS WITHOUT IMAGING CAPABILITY DURING THE SURGERIES. THE SYSTEM IS INSTALLED IN A SURGICAL CENTER AT THIS SITE AND IS BEING USED DURING ORTHOPEDIC SURGERY. THE SYSTEM PRESENTS A BLUE SCREEN COMPUTER FAILURE AND REQUIRES A REBOOT TO CORRECT THE ISSUE. AT TIMES THE REBOOT HAS NOT CORRECTED THE PROBLEM AND THE REPORTED SYSTEM DOES NOT COME BACK AND IMAGE. THERE IS NO INJURY INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCADIS AVANTIC SYSTEM, X-RAY, MOBILE IZL SIEMENS AG 10048590

    Patients

    Seq Age Sex Outcome Treatment
    1 Other