BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 9580386 · Received January 13, 2020

    Report

    Report Number
    9580386
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    November 1, 2019
    Report Date
    December 23, 2019
    Manufacturer
    GE MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO INITIATE X-RAY EQUIPMENT FOR SCHEDULED CATHETER PROCEDURE FOR AN URGENT CATHETER, AS PHYSICIAN STEPPED ON PEDAL TO ACTIVATE, X-RAY DID NOT COME ON, DESPITE MULTIPLE ATTEMPTS WITH PEDAL. SYSTEM SHUT DOWN AND RESTARTED AND THEN PEDAL WORKED. CLINICAL ENGINEERING CALLED IN WHICH I WAS DIRECTED TO INFORMATION SYSTEMS, INFORMATION SYSTEMS PAGED OUT TO CLINICAL ENGINEERING ON CALL AND WAITED FOR CALL BACK. CLINICAL ENGINEERING CALLED BACK AND STATED HE WAS AT A NEARBY SITE AND WOULD HEAD OVER WHEN HE WAS FINISHED. HE NEVER SHOWED UP. WE RESET SYSTEM AT END OF CASE AND PERFORMED AN XRAY TEST IN WHICH THE X-RAY WORKED. WE WERE PAGED IN FOR A MYOCARDIAL INFARCTION ALERT- SAME ISSUE OCCURRED WITH PEDAL AND START OF X-RAY. CATH LAB SUPERVISOR PAGED AND INFORMED OF EVENT- SHE PAGED CLINICAL ENGINEERING AGAIN AND THEY ARRIVED AFTER CASE TO CHANGE OUT THE XRAY PEDAL AND ASSESS EQUIPMENT.

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO INITIATE X-RAY EQUIPMENT FOR SCHEDULED CATHETER PROCEDURE FOR AN URGENT CATHETER, AS PHYSICIAN STEPPED ON PEDAL TO ACTIVATE, X-RAY DID NOT COME ON, DESPITE MULTIPLE ATTEMPTS WITH PEDAL. SYSTEM SHUT DOWN AND RESTARTED AND THEN PEDAL WORKED. CLINICAL ENGINEERING CALLED IN WHICH I WAS DIRECTED TO INFORMATION SYSTEMS, INFORMATION SYSTEMS PAGED OUT TO CLINICAL ENGINEERING ON CALL AND WAITED FOR CALL BACK. GARY FROM CLINICAL ENGINEERING CALLED BACK AND STATED HE WAS AT A NEARBY SITE AND WOULD HEAD OVER WHEN HE WAS FINISHED. HE NEVER SHOWED UP. WE RESET SYSTEM AT END OF CASE AND PERFORMED AN XRAY TEST IN WHICH THE X-RAY WORKED. WE WERE PAGED IN FOR A MYOCARDIAL INFARCTION ALERT- SAME ISSUE OCCURRED WITH PEDAL AND START OF X-RAY. CATH LAB SUPERVISOR PAGED AND INFORMED OF EVENT- SHE PAGED CLINICAL ENGINEERING AGAIN AND THEY ARRIVED AFTER CASE TO CHANGE OUT THE XRAY PEDAL AND ASSESS EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46317 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1