BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 10454542 · Received August 26, 2020

    Report

    Report Number
    1825014-2020-00009
    Event Type
    Injury
    Date Received
    August 26, 2020
    Report Date
    August 26, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO. LTD
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AT THE END OF A CASE, WHILE THE PATIENT WAS STILL IN THE ROOM, THE SPRING GUIDE ROD ON AN LFS MONITOR BRACKET SHEARED OFF AND FLEW ~15-20 FEET AND STUCK INTO THE FAR WALL NEAR THE CEILING. THE SPRING ALSO EJECTED AND FLEW INTO THE ROOM. THERE WAS A PATIENT ON THE TABLE AT THE TIME, AND THREE OR STAFF SITTING NEXT TO THE TABLE. THE PROJECTILE FLEW JUST A COUPLE FEET DIRECTLY OVER ALL OF THEIR HEADS AND THE PATIENT'S FEET. THE PER THE OR STAFF, THE MONITOR WAS RECENTLY SET IN THE VERTICAL POSITION. IT HAD BEEN SITTING FOR A FEW MINUTES WITH NOBODY TOUCHING IT WHEN IT SUDDENLY BROKE. THEY TOLD US THAT THEY THOUGHT THE MONITOR TIPPED UP, THEN FELL BACK DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922198 SKYTRON LFS FSY DAI-ICHI SHOMEI CO. LTD B2-610-12

    Patients

    Seq Age Sex Outcome Treatment
    1