SEDECAL X PLUS LP PLUS
Received Apr 24, 2026 · Event occurred Mar 25, 2026
Report 0001418964-2026-00003 · MDR key 24988354
Device
Generic name
Tubestand
Manufacturer
Sedecal UsaProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.
Additional Manufacturer Narrative
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.