BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO GRVTY FLR SYSTM 6.5' ARM

    MDR report key: 22378223 · Received July 1, 2025

    Report

    Report Number
    2182318-2025-00067
    Event Type
    Injury
    Date Received
    July 1, 2025
    Report Date
    June 6, 2025
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    EAJ
    UDI-DI
    00618125176250
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT REPORTS 2 STAFF MEMBERS GOT INJURED TRYING TO MOVE A ZG FLOOR SYSTEM. THE 2 EMPLOYEES HAVE NO EXPERIENCE WITH ZERO GRAVITY AND PROBABLY SHOULDN'T HAVE ATTEMPTED TO MOVE THE SYSTEM WITHOUT THE APPROPRIATE TRAINING. THE SYSTEM HASN'T BEEN USED FOR QUITE SOME TIME SO THERE IS A LACK OF KNOWLEDGE ON HOW TO MOVE AND USE THE DEVICE. THERE WERE NO REPORTS OF THE SYSTEM BEING DEFECTIVE. EMPLOYEE 1 SUSTAINED A SERIOUS TOE INJURY DUE TO THE SYSTEM ROLLING/PUSHED OVER HER TOE. THE 2ND EMPLOYEE SUSTAINED A CALF STRAIN TRYING TO PUSH THE ZERO GRAVITY. THIS IS THE FIRST REPORTED COMPLAINT OF THIS TYPE, BASED ON HISTORICAL COMPLAINT DATA REVIEW. PER THE TIDI ZERO GRAVITY SALES CONSULTANT, TRAINING WAS PROVIDED TO THE STAFF ON (B)(6) 2025. NO DOCUMENTATION OF THE TRAINING HAS BEEN PROVIDED AS OF YET. PER THE INSTRUCTIONS FOR USE (IFU): WARNING! TIP OVER HAZARD LOWER ASSEMBLY TO LOWEST HEIGHT PRIOR TO TRANSPORT. WARNING! TIP OVER HAZARD. TO RELOCATE DEVICE IN SURGICAL SUITE: RAISE LEVELING FEET; ROLL OVER FLAT SURFACES WITH NO OBSTRUCTIONS. WITHIN THE SURGICAL SUITE OR TO OTHER ROOMS. THE FLOOR UNIT MAY BE MOVED TO OTHER ROOMS IF DISASSEMBLY IS NOT REQUIRED. IF DISASSEMBLY IS REQUIRED, CONTACT TIDI PRODUCTS SERVICE. 1. RAISE LEVELING FEET AND UNLOCK CASTERS. 2. CAREFULLY PUSH BASE, USING HANDLES, OVER FLAT SURFACE WITH NO OBSTRUCTIONS. 3. LEVEL THE BASE ACCORDING TO THIS DOCUMENT. SERVICE ISSUES ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, TRENDS AND EXCURSIONS ABOVE CONTROL LIMITS WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANTED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT THIS TIME MANUFACTURER REFERENCE FILE: (B)(4).

    Description of Event or Problem · 0

    2 STAFF MEMBERS GOT INJURED TRYING TO MOVE A ZG FLOOR SYSTEM. THE 2 EMPLOYEES HAVE NO EXPERIENCE WITH ZERO GRAVITY AND ATTEMPTED TO MOVE THE SYSTEM WITHOUT THE APPROPRIATE TRAINING ACCORDING TO THE CONTACT AT THE HOSPITAL. THE SYSTEM HASN'T BEEN USED FOR QUITE SOME TIME SO THERE IS A LACK OF KNOWLEDGE ON HOW TO MOVE AND USE THE DEVICE. THERE WERE NO REPORTS OF THE SYSTEM BEING DEFECTIVE. EMPLOYEE 1 SUSTAINED A SERIOUS TOE INJURY DUE TO THE SYSTEM ROLLING/PUSHED OVER HER TOE. THE 2ND EMPLOYEE SUSTAINED A CALF STRAIN TRYING TO PUSH THE ZERO GRAVITY. BUTLER WAS INFORMED THAT TIDI WOULD SEND SOMEONE THERE TO DO AN IN-SERVICE AND TRAIN THEM HOW TO MOVE AND OPERTATE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431483 ZERO GRVTY FLR SYSTM 6.5' ARM APRON, LEADED EAJ TIDI PRODUCTS LLC ZGM-6-5H UNKNOWN 00618125176250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other