BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO GRAVITY LOW FLOOR SYSTEM 6.5 FT ARM

    MDR report key: 23929577 · Received December 30, 2025

    Report

    Report Number
    2182318-2025-00114
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Report Date
    December 8, 2025
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    EAJ
    UDI-DI
    00618125176250
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ON 12/08/2025, THE CUSTOMER REQUESTED A QUOTE FOR A REPLACEMENT ZG BALANCER. THE CUSTOMER REPORTED THAT THERE WAS SOME RESISTANCE WHEN ATTEMPTING TO RETRACT THE LEAD APRON. THE CUSTOMER NOTED THAT THERE WAS NO VISIBLE DAMAGE TO THE SHEATHING AROUND THE CABLE. THE CABLE HAD PREVIOUSLY BEEN UPGRADED ON 02/12/2021. THE AFFECTED DEVICE IS A ZGM-6-5H BALANCER, SERIAL NUMBER (B)(6), MANUFACTURED IN MARCH 2014. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AN THEREFORE, THIS EVENT IS REPORTED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. BASED ON THE INFORMATION PROVIDED, THE REPORTED RESISTANCE MAY BE RELATED TO INTERNAL WEAR OR MECHANICAL COMPONENTS WITHIN THE BALANCER ASSEMBLY. WITHOUT THE PRODUCT FOR INVESTIGATION, THE ROOT CAUSE CANNOT BE CONFIRMED. INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR SAFE AND EFFECTIVE USE OF THE DEVICE. USER GUIDE STATES: USE SAFETY CONFIRM THAT SYSTEM HAS BEEN INSTALLED PER THE TIDI PRODUCTS ISSUED INSTALLATION GUIDE. FAILURE TO MAINTAIN CONTROL OF COLUMN, WHEN RAISING OR LOWERING, CAN RESULT IN PERSONAL INJURY OR PROPERTY DAMAGE. DO NOT ATTEMPT TO RELOCATE FLOOR UNIT DURING A PROCEDURE. INCORRECT SYSTEM POSITIONING OR ADJUSTMENT MAY CAUSE PERSONAL INJURY OR EQUIPMENT DAMAGE. USER MANUAL IS EXPLICIT IN ADVISING THE CUSTOMER TO INSPECT FOR ANY MISSING OR DAMAGED COMPONENTS PRIOR TO USE WITH A PATIENT, AND TO NOT USE THE UNIT IF ANY DAMAGE IS FOUND. MANUFACTURER REFERENCE FILE: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER ASKED FOR QUOTE FOR A REPLACEMENT ZG BALANCER, SHE STATED THERE IS SOME RESISTANCE WHEN YOU ARE TRYING TO RETRACT THE LEAD APRON. NO DAMAGE TO THE SHEATHING AROUND THE CABLE NOTICED BY THE CUSTOMER. CABLE WAS UPGRADED ON 2/12/21 MODEL: ZGM-6-5H, SERIAL#: (B)(6), MANUFACTURED 3-2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271792 ZERO GRAVITY LOW FLOOR SYSTEM 6.5 FT ARM APRON, LEADED EAJ TIDI PRODUCTS LLC ZGM-6-5H 00618125176250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown