BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGENUITY CT

    MDR report key: 12632486 · Received October 14, 2021

    Report

    Report Number
    3015777306-2021-10012
    Event Type
    Death
    Date Received
    October 14, 2021
    Date of Event
    September 5, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    JAK
    UDI-DI
    00884838059504
    PMA / PMN Number
    K160743
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE REPORTED WAS THAT DURING A HEAD/NECK CT ANGIO EXAM, AN ERROR OCCURRED AND THE SYSTEM FAILED TO EXPOSE. THE CUSTOMER STATED THAT THEY STOPPED THE PATIENT SCAN AND ALLEGED THAT THIS RESULTED IN A DELAYED RESCUE RESULTING IN THE PATIENT'S DEATH APPROXIMATELY 20 DAYS LATER. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPORTED TO THE SITE TO EVALUATE THE REPORTED ISSUE. THE FSE REVIEWED LOGFILES FROM THE SYSTEM AND FOUND KPM&APM OVER CURRENT FAULT ERRORS, AND, FILAMENT CALIBRATION HAD NOT BEEN PERFORMED ON A REGULAR BASIS FOR OVER A YEAR. THE FSE PERFORMED FILAMENT CALIBRATION TO RESOLVE THE ISSUE AND THE SYSTEM RETURNED TO SPECIFICATION FOR CLINICAL USE. THE PHILIPS MEDICAL AFFAIRS OFFICER AND CLINICAL VALIDATION SPECIALIST REVIEWED ALL OF THE INFORMATION REGARDING THIS EVENT. AFTER EVALUATING THE EVENT DETAILS, IT WAS CONFIRMED THAT THE CT FAILURE WAS NOT CONSIDERED TO HAVE CONTRIBUTED DIRECTLY, AND, MOST LIKELY NOT EVEN INDIRECTLY TO THE PATIENT'S DEATH. THE PROBABLE CAUSE: APM/CPM OVER CURRENT DUE TO FILAMENT CALIBRATION NOT PERFORMED ON THE RECOMMENDED REGULAR BASIS. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4). HEALTH IMPACT CODE: C28554 - THE CESSATION OF LIFE. DATE OF REPORT: 20211112.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: ADDED THE HEALTH IMPACT CODE TO THE HEALTH IMPACT GRID UPDATED THE "TYPE OF REPORTED COMPLAINT" TO DEATH. THIS WAS MARKED ON THE FOLLOW UP REPORT AS "PRODUCT PROBLEM" IN ERROR. INTERNAL CROSS REFERENCE: COMPLAINT (B)(4). DATE OF REPORT: 20211130.

    Additional Manufacturer Narrative · 1

    WE HAVE NOT COMPLETED OUR INVESTIGATION OF THIS EVENT. WE WILL FILE A FOLLOW-UP EMDR AT THE COMPLETION OF THE INVESTIGATION. INTERNAL CROSS REFERENCE: COMPLAINT PR # (B)(4). DATE OF REPORT: 2021-10-14.

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE ISSUE REPORTED WAS THAT DURING A HEAD/ NECK CT ANGIO EXAM, THE SYSTEM HAD AN ERROR AND WOULD NOT EXPOSE. THE CUSTOMER STATED THEY STOPPED THE PATIENT SCAN. THE CUSTOMER HAS ALLEGED THAT THIS RESULTED IN A DELAYED RESCUE RESULTING IN THE PATIENT'S DEATH APPROXIMATELY 20 DAYS LATER. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE HAS BEEN INITIALLY DETERMINED TO BE A REPORTABLE EVENT AND IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530596 INGENUITY CT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY ELITE 128 00884838059504

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Death