BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BV300 9"

    MDR report key: 4844193 · Received June 15, 2015

    Report

    Report Number
    3003768277-2015-00049
    Event Type
    Injury
    Date Received
    June 15, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 21, 2015
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OXO
    PMA / PMN Number
    K953910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT TO FDA.

    Additional Manufacturer Narrative · 1

    PHILIPS UNDERSTOOD THAT THE SYSTEM IS SERVICED BY A THIRD PARTY COMPANY THEREFORE, WE WERE NOT INFORMED ABOUT THE REPORTED ISSUE UNTIL WE RECEIVED THE MEDWATCH REPORT FROM THE FDA. IT IS NOT KNOWN WHO THE 3RD COMPANY IS OR WHICH 3RD PARTY ENGINEER CHECKED THE SYSTEM; THEREFORE, THE CAUSE OF THE REPORTED ISSUE IS UNKNOWN. THE CUSTOMER HAS BEEN CONTACTED BY PHILIPS AND THERE WERE NO MORE COMPLAINTS REGARDING THE SYSTEM. THE SYSTEM HAS BEEN USED TWICE SINCE THE REPORTED ISSUE OCCURRED IN (B)(6). THE SYSTEM IS END OF SERVICE SINCE 2010, THEREFORE WE TAKE NO FURTHER ACTION IN THIS MATTER (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT DURING THE INSERTION OF A PACEMAKER THE FLUOROSCOPY DID NOT FUNCTION AFTER A SECOND PARALLEL WIRE WAS PASSED. CALLS WERE MADE TO THE SERVICE REPRESENTATIVE BY THE RADIOLOGY TECHNICIAN AND THE DEVICE WAS SUBSEQUENTLY RESTARTED AND FUNCTIONED. PATIENT STATUS UNCHANGED AND REMAINED STABLE AFTER COMPLETION OF THE PROCEDURE.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM A CUSTOMER THAT DURING THE INSERTION OF A PACEMAKER THE FLUOROSCOPY DID NOT FUNCTION AFTER A SECOND PARALLEL WIRE WAS PASSED. CALLS WERE MADE TO THE SERVICE REPRESENTATIVE BY THE RADIOLOGY TECHNICIAN AND THE DEVICE WAS SUBSEQUENTLY RESTARTED AND FUNCTIONED. PATIENT STATUS UNCHANGED AND REMAINED STABLE AFTER COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387911 BV300 9" IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE OXO PHILIPS HEALTHCARE 71815

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening