BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTIDIAGNOST ELEVA WITH FLAT

    MDR report key: 6933987 · Received October 10, 2017

    Report

    Report Number
    3003768277-2017-00084
    Event Type
    Death
    Date Received
    October 10, 2017
    Date of Event
    September 30, 2017
    Report Date
    September 30, 2017
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    KPR
    PMA / PMN Number
    K961374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE PROCESSING PC MALFUNCTIONED WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

    Additional Manufacturer Narrative · 1

    PHILIPS ANALYZED THE LOGGING AND NOTICED A CRYSTALLOGRAPHIC IMAGE PROCESSING ( CRISP) IMAGE PC WARNING THAT AN EXPORT TASK DID NOT START. NO ADDITIONAL INFORMATION IS PRESENT IN THE LOGGING. THE NON-FUNCTIONAL CRISP COULD HAVE BEEN THE REASON WHY THE MD ELEVA DID NOT START-UP. SINCE THE SYSTEM DID NOT START-UP, NO OTHER LOGGING INFORMATION IS AVAILABLE. NO INVESTIGATION COULD BE DONE ON THE CRYSTALLOGRAPHIC IMAGE PROCESSING (CRISP) AS THE PART WAS NOT AVAILABLE FOR ANALYSIS. THE CRYSTALLOGRAPHIC IMAGE PROCESSING (CRISP) WAS REPLACED AND THIS SOLVED THE PROBLEM. SEARCH ON REPLACED PARTS IN THE PAST FOR THIS SYSTEM SHOW THAT THIS IS THE FIRST TIME THAT THE IP PC HAS BEEN REPLACED. THE SYSTEM WAS INSTALLED IN 2007 AND THEREFORE WE CONCLUDE THAT THIS NORMAL WEAR AND TEAR AFTER 10 YEARS. TREND DATA OF THIS PART DOES NOT SHOW ANY EXCEPTIONAL REPLACEMENT RATE. NO SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED. NO ADDITIONAL ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT IN WHICH IT WAS STATED THAT A PATIENT WAS GOING TO RECEIVE AN EMERGENCY PROCEDURE WITH A MULTI DIAGNOST ELEVA SYSTEM. AS THE SYSTEM DID NOT START PROPERLY, THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM WHERE THE PATIENT WAS TREATED. THE PROCEDURE WAS FINISHED AND THE PATIENT WAS RETURNED TO THE RESUSCITATION DEPARTMENT. LATER THE PATIENT DIED. ACCORDING TO THE MEDICAL STAFF THE DELAY IN TREATMENT COULD HAVE CONTRIBUTED TO THE OUTCOME OF THE PATIENT. THE HOSPITAL IS ALSO INVESTIGATING THE CAUSE OF THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718047 MULTIDIAGNOST ELEVA WITH FLAT SYSTEM, X-RAY, STATIONARY KPR PHILIPS HEALTHCARE 708034

    Patients

    Seq Age Sex Outcome Treatment
    1 Death