BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS-7

    MDR report key: 7479460 · Received May 2, 2018

    Report

    Report Number
    7479460
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    December 18, 2017
    Report Date
    April 4, 2018
    Manufacturer
    KONICA MINOLTA HEALTHCARE AMERICAS, INC.
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CHEST X-RAY WAS DONE WITH BABY HEAD DOWN IN A GIRAFFE BED DUE TO POSITIONING FOR THE ENDOTRACHEAL TUBE CONNECTED TO OSCILLATOR AT THE FOOT OF THE BED AND THE BABY COULD NOT BE REPOSITIONED. TECHNOLOGIST ROTATED THE IMAGE UP/DOWN ON THE MACHINE FOR THE DOCTOR TO BE ABLE TO VIEW THE IMAGE IN A HEAD-UP POSITION ON THE PORTABLE SCREEN. TECH VERBALIZED THAT SHE WAS UNSURE BUT THOUGHT THE LATERALITY MIGHT BE FLIPPED DUE TO THE UP/DOWN FLIP. BECAUSE OF A LARGE TENSION PNEUMOTHORAX, ANATOMIC MARKERS WERE NOT CLEAR. TECHNOLOGIST LEFT THE NICU TO RETURN TO IMAGING AND ANNOTATE LATERALITY WITH THE ASSISTANCE OF HER TEAM LEAD. MEANWHILE, THE BABY CONTINUES TO DECLINE AND A CODE IS INITIATED. THE DOCTOR DETERMINED A CHEST TUBE WAS NEEDED EMERGENTLY. WITHIN A FEW MINUTES OF THE X-RAY BEING TAKEN, BEFORE THE OFFICIAL RADIOLOGY READ, THE NICU PHYSICIAN PLACES A CHEST TUBE BASED ON THE IMAGE HE VIEWED ON THE PORTABLE MONITOR. ROUTINE CONFIRMATION X-RAY OF THE CHEST TUBE SHOWS IT WAS PLACED ON THE OPPOSITE SIDE THAN INTENDED. A SECOND CHEST TUBE IS PLACED TO ADDRESS THE ORIGINAL PNEUMOTHORAX. FOLLOW UP SIMULATION OF THE EVENT DETERMINED A VERY COMPLEX SOFTWARE INTERFACE MADE IT CHALLENGING FOR TECHNOLOGISTS TO QUICKLY SELECT IMAGE ADJUSTMENT OPTIONS AND CLEARLY UNDERSTAND HOW THE SELECTION MIGHT IMPACT THE IMAGE IN MULTIPLE DIRECTIONS.

    Description of Event or Problem · 1

    CHEST X-RAY WAS DONE WITH BABY HEAD DOWN IN A GIRAFFE BED DUE TO POSITIONING FOR THE ENDOTRACHEAL TUBE CONNECTED TO OSCILLATOR AT THE FOOT OF THE BED AND THE BABY COULD NOT BE REPOSITIONED. TECHNOLOGIST ROTATED THE IMAGE UP/DOWN ON THE MACHINE FOR THE DOCTOR TO BE ABLE TO VIEW THE IMAGE IN A HEAD-UP POSITION ON THE PORTABLE SCREEN. TECH VERBALIZED THAT SHE WAS UNSURE BUT THOUGHT THE LATERALITY MIGHT BE FLIPPED DUE TO THE UP/DOWN FLIP. BECAUSE OF A LARGE TENSION PNEUMOTHORAX, ANATOMIC MARKERS WERE NOT CLEAR. TECHNOLOGIST LEFT THE NICU TO RETURN TO IMAGING AND ANNOTATE LATERALITY WITH THE ASSISTANCE OF HER TEAM LEAD. MEANWHILE, THE BABY CONTINUES TO DECLINE AND A CODE IS INITIATED. THE DOCTOR DETERMINED A CHEST TUBE WAS NEEDED EMERGENTLY. WITHIN A FEW MINUTES OF THE X-RAY BEING TAKEN, BEFORE THE OFFICIAL RADIOLOGY READ, THE NICU PHYSICIAN PLACES A CHEST TUBE BASED ON THE IMAGE HE VIEWED ON THE PORTABLE MONITOR. ROUTINE CONFIRMATION X-RAY OF THE CHEST TUBE SHOWS IT WAS PLACED ON THE OPPOSITE SIDE THAN INTENDED. A SECOND CHEST TUBE IS PLACED TO ADDRESS THE ORIGINAL PNEUMOTHORAX. FOLLOW UP SIMULATION OF THE EVENT DETERMINED A VERY COMPLEX SOFTWARE INTERFACE MADE IT CHALLENGING FOR TECHNOLOGISTS TO QUICKLY SELECT IMAGE ADJUSTMENT OPTIONS AND CLEARLY UNDERSTAND HOW THE SELECTION MIGHT IMPACT THE IMAGE IN MULTIPLE DIRECTIONS. HUMAN FACTORS ENGINEER COMPLETED USABILITY STUDY OF THE (B)(6) SOFTWARE INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323712 CS-7 SYSTEM, IMAGE PROCESSING, RADIOLOGICAL MQB KONICA MINOLTA HEALTHCARE AMERICAS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other NO