BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERADIUS

    MDR report key: 4223521 · Received October 29, 2014

    Report

    Report Number
    3003768277-2014-00123
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K090590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT AN ERROR "GENERATOR NOT AVAILABLE" OCCURRED DURING A PROCEDURE. SYSTEM NEEDED TO BE REBOOTED MULTIPLE TIMES BEFORE THE PROCEDURE COULD BE FINISHED. THE PROCEDURE WAS DELAYED BY 23 MINUTES DURING THESE REBOOTS. DURING THAT TIME , THE PT HAD A CATHETER IN BILE DUCT AND THE PHYSICIAN FEELS THIS MAY HAVE CONTRIBUTED TO PANCREATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692726 VERADIUS INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 718131

    Patients

    Seq Age Sex Outcome Treatment
    1 Other