BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGENUITY CT

    MDR report key: 5257189 · Received December 1, 2015

    Report

    Report Number
    1525965-2015-00292
    Event Type
    Death
    Date Received
    December 1, 2015
    Report Date
    November 17, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
    Product Code
    JAK
    PMA / PMN Number
    K033326
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTED THAT ON (B)(6) 2015, AFTER A PATIENT PROCEDURE WAS COMPLETED, THE SYSTEM WAS INOPERABLE. THE CUSTOMER STATED THAT THE PATIENT (MALE, AGE-UNKNOWN) WAS BEING EVALUATED FOR GUN SHOT WOUNDS AND HAD DIED AS A RESULT OF CARDIAC ARREST FROM THEIR INJURIES WHILE ON THE PHILIPS INGENUITY CT SYSTEM. THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS NOT RELATED TO ANY MALFUNCTION OF THE CT SYSTEM. THE CUSTOMER REPORTED THAT DUE TO THE PATIENT'S INJURIES FROM THE GUN SHOTS, A LARGE AMOUNT OF BLOOD HAD LEAKED ONTO THE SYSTEM MYLAR RING AND INTO THE GANTRY. ON 18-NOV-2015, A PHILIPS FIELD SERVICE ENGINEER (FSE) EVALUATED THE CT SYSTEM AND CONFIRMED THAT THE GANTRY WAS NOT ABLE TO TURN ON AFTER THE INCIDENT BECAUSE OF BLOOD CONTAMINATION WITHIN THE GANTRY. THE FSE CLEANED THE BLOOD FROM THE GANTRY AND REBOOTED THE SYSTEM, HOWEVER, THE FSE WAS UNABLE TO PERFORM SCANS WITH THE SYSTEM. FURTHER EVALUATION OF THE SYSTEM BY THE FSE DETERMINED THAT THE NEXT GENERATION BACK PROJECTOR (NGBP) WITHIN THE COMMON IMAGE RECONSTRUCTION SYSTEM (CIRS) HAD FAILED. THE FSE REPLACED THE NGBP WITHIN THE CIRS AND THEN CONFIRMED THAT THE SYSTEM WAS PERFORMING WITHIN PHILIPS RECOMMENDED SPECIFICATIONS BEFORE RETURNING THE SYSTEM TO NORMAL CLINICAL USE TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2015, AFTER A PATIENT PROCEDURE WAS COMPLETED, THE SYSTEM WAS INOPERABLE. THE CUSTOMER STATED THAT THE PATIENT (MALE, AGE-UNKNOWN) WAS BEING EVALUATED FOR GUN SHOT WOUNDS. THE PATIENT HAD DIED AS A RESULT OF CARDIAC ARREST FROM HIS INJURIES WHILE ON THE PHILIPS INGENUITY CT SYSTEM. THE CUSTOMER CONFIRMED THAT THE PATIENT DEATH WAS NOT RELATED TO ANY MALFUNCTION OF THE CT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789654 INGENUITY CT SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.

    Patients

    Seq Age Sex Outcome Treatment
    1