ZERO GRVTY FLR SYSTM 6.5' ARM
Received Mar 18, 2026
Report 2182318-2026-00034 · MDR key 24628623
Device
Product problems
- Unintended Movement
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
H3: ON (B)(6), 2026, TIDI WAS CONTACTED BY THE CUSTOMER REGARDING A QUOTE FOR A BROKEN END STOP THAT IS LOCATED ON THE TOP OF THE BLOCK ASSEMBLY. IT WAS REPORTED THAT ONE OF THE TWO SCREWS OF THE STOP BLOCK WERE SHEARED OFF AND IT IS UNKNOWN HOW IT BROKE. ON (B)(6) 2026, THE CUSTOMER AGAIN CONTACTED TIDI AND INFORMED US THAT THE SCREWS HAD BEEN SHEARED OFF WHILE THE UNIT WAS BEING MOVED BY AN UNKNOWN INDIVIDUAL. AS A RESULT, THE BOOM ARM ROTATED AND REPORTEDLY CAUSED INJURY TO TWO INDIVIDUALS; HOWEVER, THE IDENTITIES OF THE INDIVIDUALS AND THE NATURE OR SEVERITY OF THE INJURIES WERE NOT PROVIDED. THE REPORT DID NOT INDICATE THAT THE UNIT TIPPED OVER. AN ATTEMPT WAS MADE TO GATHER MORE INFORMATION ABOUT THE EVENT AND INJURIES, BUT NO FURTHER INFORMATION WAS AVAILABLE. AT THE TIME OF REPORTING, THE UNIT IS UNDER THE USER¿S QUALITY ASSURANCE CONTROL FOR INVESTIGATION TO DETERMINE ROOT CAUSE. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. PER THE IFU: ¿THE FLOOR UNIT MAY BE MOVED TO OTHER ROOMS IF DISASSEMBLY IS NOT REQUIRED. IF DISASSEMBLY IS REQUIRED, CONTACT TIDI PRODUCTS SERVICE.¿ AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS REVIEW PROCESS, ANY EXCURSION ABOVE ESTABLISHED CONTROL LIMITS FOR THIS FAILURE MODE IS ASSESSED, DOCUMENTED, AND ADDRESSED AS APPROPRIATE. MANUFACTURER REFERENCE FILE: (B)(4).
Description of Event or Problem
THE SCREWS WERE SHEARED OFF WHEN MOVING THE UNIT BY UNKNOWN AND THE BOOM ARM ROTATED INJURING 2 PEOPLE (UNKNOWN WHO AND WHAT INJURY) BUT DID NOT MENTION THE UNIT TIPPING OVER.