BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKYTRON

    MDR report key: 10579198 · Received September 24, 2020

    Report

    Report Number
    3006437518-2020-00003
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    July 31, 2020
    Report Date
    September 14, 2020
    Manufacturer
    DAI-ICHI SHOMEI CO. LTD.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, DKK RECEIVED INFORMATION THAT AT THE END OF A CASE THE SPRING GUIDE ROD ON A 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. WHEN IT HAPPENED, THE PATIENT AND THREE OR STAFF WERE STILL IN THE ROOM. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049127 SKYTRON LFS FSY DAI-ICHI SHOMEI CO. LTD. B2-610-12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown