BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISIO NAVIGATION SYSTEM

    MDR report key: 20697053 · Received November 15, 2024

    Report

    Report Number
    3014653199-2024-00002
    Event Type
    Malfunction
    Date Received
    November 15, 2024
    Date of Event
    October 24, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ELUCENT MEDICAL, INC.
    Product Code
    NEU
    UDI-DI
    00851674008034
    PMA / PMN Number
    K183400
    Removal / Correction Number
    3014653199-12022024-001-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO INJURY REPORTED WITH THIS EVENT. USE OF THE ENVISIO NAVIGATION SYSTEM REQUIRES THE USE OF X-RAY RISER STANDS ON THE SURGICAL BED. FOR PATIENT COMFORT, THE ENVISIO NAVIGATION SYSTEMS INCLUDE A PATIENT PAD TRANSITION CUSHION WHICH IS INTENDED TO FIT BETWEEN THE RISERS ON BOTH THE BACK AND SEAT SECTIONS OF THE SURGICAL BED. WHEN THE BACK PORTION OF THE SKYTRON BED (MODEL SERIES 3600, 6500, 6600 AND 6700) IS INCLINED GREATER THAN 40 DEGREES IN THE VERTICAL POSITION, THE ENVISIO PATIENT PAD TRANSITION CUSHION IS COMPRESSED BETWEEN THE RISERS. THIS COMPRESSION MAY RESULT IN ENOUGH BACK-PRESSURE TO FORCE DISASSOCIATION OF THE BACK SECTION OF SOME SKYTRON BEDS.

    Description of Event or Problem · 0

    DURING A CASE WHICH WAS SETUP WITH THE ENVISIO NAVIGATION SYSTEM, IT WAS REPORTED THAT THE SKYTRON 6702 OR BED WAS INCLINED TO A NEAR VERTICAL POSITION. AS THE BACK SECTION OF THE OR BED INCLINED A COMPONENT OF THE ENVISIO NAVIGATION SYSTEM, THE ENVISIO PATIENT PAD TRANSITION PAD WAS COMPRESSED BETWEEN THE X-RAY RISERS ON THE BACK AND SEAT SECTIONS OF THE OR BED. THE COMPRESSION OF THE PATIENT PAD TRANSITION CUSHION CAUSED SUFFICIENT BACK PRESSURE TO CAUSE THE BACK PORTION OF THE SKYTRON OR BED BECAME DISASSOCIATED FROM THE BED FRAME. THERE WAS NO REPORTED PATIENT INJURY RESULTING FROM THIS EVENT. ELUCENT IS FILING THIS REPORT DUE TO THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1334631 ENVISIO NAVIGATION SYSTEM ENVISIO NAVIGATION SYSTEM NEU ELUCENT MEDICAL, INC. N/A 00851674008034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female