BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL X PLUS LP PLUS

    MDR report key: 24988354 · Received April 24, 2026

    Report

    Report Number
    0001418964-2026-00003
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 24, 2026
    Manufacturer
    SEDECAL USA
    Product Code
    IXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON MARCH 26, 2026, TS HAD THE DR LOG FILES PULLED AND SENT TO THE SOFTWARE DEVELOPER. ON APRIL 20, 2026, THE SOFTWARE DEVELOPER CONFIRMED THAT THE EVENT LOGS FROM THE U-ARM DID NOT SHOW ANY ACTIVITY DURING THE TIMEFRAME IN WHICH THE ADVERSE EVENT OCCURRED, INDICATING THAT THIS WAS A USER ERROR. DEL MEDICAL INC IS A DISTRIBUTER, NOT MANUFACTURER OF THIS DEVICE. THE ORIGINAL MANUFACTURER, SEDECAL USA HAS BEEN NOTIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE CUSTOMER CONTACTED TS TO REPORT THAT THE U-ARM RECEPTOR MADE CONTACT WITH THE MOBILE TABLE, LIFTING IT 3-5 INCHES OFF THE FLOOR WHILE SETTING UP AN ANKLE TO HIP STUDY. A PEDIATRIC PATIENT WAS ON THE TABLE WHEN THIS EVENT OCCURRED BUT NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569269 SEDECAL X PLUS LP PLUS TUBESTAND IXY SEDECAL USA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female