BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 7984753 · Received October 19, 2018

    Report

    Report Number
    3003768277-2018-00078
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Report Date
    September 20, 2018
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K141979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Additional Manufacturer Narrative · 1

    PHILIPS INVESTIGATED THIS COMPLAINT. PHILIPS CHECKED THE SYSTEM ON SITE AND FOUND THAT A DEFECTIVE HOST PC CAUSED THE ISSUE REPORTED. THE HOST PC WAS REPLACED AND THE SYSTEM WAS RETURNED TO THE CUSTOMER IN WORKING ORDER. INVESTIGATION OF THE REPLACED HOST PC SHOWED THAT THE POWER SUPPLY (PSU) OF THE HOST PC FAILED.

    Description of Event or Problem · 1

    PHILIPS HAS RECEIVED THROUGH THE (B)(6) MEDICAL DEVICES SENTINEL NETWORK A REPORT SUBMITTED BY A CUSTOMER. IN THIS REPORT THE CUSTOMER REPORTED ¿THE ELECTROPHYSIOLOGY TEAM WERE IN THE MIDDLE OF AN ELECTROPHYSIOLOGY STUDY WITH A PATIENT WHEN, WITHOUT WARNING, TOTAL IMAGING CHAIN EQUIPMENT FAILURE OCCURRED. DUE TO THE NATURE OF THE PROCEDURE BEING COMPLETED AT THE TIME OF THE EQUIPMENT FAILURE, AND ANCILLARY MAPPING EQUIPMENT BEING USED, THE TEAM WERE ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE PATIENT OUTCOMES. HAD THE FAILURE OCCURRED AT A DIFFERENT STAGE OF THE ELECTROPHYSIOLOGY STUDY, OR WITH ANOTHER PROCEDURE COMMONLY PERFORMED IN THE ELECTROPHYSIOLOGY LABORATORY, PATIENT OUTCOME COULD HAVE BEEN NEGATIVELY IMPACTED. THE PHILIPS TECHNICIANS PERFORMED AN ASSESSMENT AND DETERMINED THAT THE FAILURE WAS DUE TO A COMPUTER BOARD IMPACTING COMPLETE FUNCTIONALITY OF THE IMAGING CHAIN SYSTEM. UNKNOWN TO THE TEAM AT THE TIME OF THE FAILURE, THE IMAGING CHAIN TABLE WAS IN A FREE FLOATING STATE POSING ADDITIONAL RISK TO PATIENT AND EMPLOYEE SAFETY. THE CEILING MOUNTED IMAGING CHAIN SYSTEM WAS A (B)(6) INVESTMENT WILL ACCEPTANCE TESTING COMPLETED IN (B)(6) 2016. FULL TIME (5 DAYS/WEEK) LABORATORY UTILIZATION DID NOT OCCUR UNTIL (B)(6) 2017. SUCH CATASTROPHIC FAILURES SHOULD NOT BE EXPERIENCED WITH NEW, FULLY SERVICED EQUIPMENT. IN ADDITION TO THE NEAR MISS EVENT, THE PROGRAM LOST 1.25 DAYS OF LABORATORY TIME WITH THIS EQUIPMENT FAILURE. IF THIS IS A COMMON ISSUE WITH THE NEW PHILIPS TECHNOLOGY, IT IS A HUGE ISSUE¿..IF THIS HAD OCCURRED IN THE MIDDLE OF AN ANGIOPLASTY WE WOULD HAVE ESSENTIALLY LOST OUR ABILITY TO SEE WHAT WE WERE DOING IN THE CORONARY ARTERY SYSTEM¿AND THAT CAN RESULT IN A CATASTROPHIC EVENT INCLUDING DEATH¿. BECAUSE OF THE ALLEGATION ON POTENTIAL HARM THIS REPORT IS BEING SUBMITTED. PHILIPS HAS INITIATED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828197 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722028

    Patients

    Seq Age Sex Outcome Treatment
    1