BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO GRAVTY HNGD SWNG ARM SYST

    MDR report key: 23639314 · Received November 24, 2025

    Report

    Report Number
    2182318-2025-00102
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Report Date
    October 22, 2025
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    EAJ
    UDI-DI
    00618125176229
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: DURING PREVENTATIVE MAINTENANCE, IT WAS NOTED BY SERVICE TECHNICIAN THAT THE SET SCREWS AND JAM NUTS ON THE UNIT DID NOT MEET OEM STANDARDS. THE UNIT WAS PREVIOUSLY PURCHASED FROM ANOTHER HOSPITAL, THOUGH THE DATE OF PURCHASE IS UNKNOWN. THE UNIT WAS ALSO RELOCATED AT SOME POINT. THIS IS AN OLDER MODEL ORIGINALLY SOLD BY CFI. TO BRING THE UNIT BACK TO OEM STANDARDS, REPLACEMENT OF THE UPPER BOOM ARM WOULD BE REQUIRED. BASED ON AVAILABLE INFORMATION, THE DEVIATION APPEARS TO BE THE RESULT OF AFTERMARKET MODIFICATIONS OR REPAIRS PERFORMED OUTSIDE OF TIDI¿S CONTROL. DEVICE EVALUATION: THE UNIT WAS NOT RETURNED FOR FORMAL EVALUATION. HOWEVER, THE REPORTED FINDINGS SUGGEST USE OF NON-ORIGINAL PARTS NOT SUPPLIED OR INSTALLED BY THE MANUFACTURER. NO INTERNAL SME INVOLVEMENT IS REQUIRED AT THIS TIME, AND THE ISSUE APPEARS RELATED TO UNAUTHORIZED ALTERATIONS RATHER THAN A MANUFACTURING DEFECT. MANUFACTURER REFERENCE FILE: (B)(4).

    Description of Event or Problem · 0

    DURING PREVENTATIVE MAINTENANCE, IT WAS NOTICED BY THE TECHNICIAN, THAT THE SET SCREWS AND JAM NUTS ARE NOT TO OEM STANDARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294148 ZERO GRAVTY HNGD SWNG ARM SYST APRON, LEADED EAJ TIDI PRODUCTS LLC ZGHSA 567605-3 00618125176229

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown