BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO GRAVITY CONTOUR TRACK SYSTEM

    MDR report key: 16259759 · Received January 27, 2023

    Report

    Report Number
    2182318-2023-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Report Date
    January 3, 2023
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    EAJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: DEVICE EVALUATION IS EXPECTED, BUT NOT YET PERFORMED. THIS EVENT WAS INITIALLY REPORTED TO THE DISTRIBUTOR, BIOTRONIK. IT WAS REPORTED THAT THE SCREW COVERS ON THE RAIL WERE FALLING INTO THE STERILE FIELD. THERE WAS NO PATIENT OR CAREGIVER INJURY REPORTED AS A RESULT OF THIS EVENT. THE UNIT HAS BEEN TAKEN OUT OF USE, CURRENTLY. THIS IS THE FIRST REPORTED COMPLAINT OF THIS TYPE, BASED ON HISTORICAL COMPLAINT DATA REVIEW. THE SCREW COVERS ARE SPECIFIC TO THIS ZERO GRAVITY MODEL, WHICH HAS BEEN DISCONTINUED. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. THE ORIGINAL MALFUNCTIONING COMPONENT IS BEING REQUESTED TO BE RETURNED FOR EVALUATION, BUT HAS NOT BEEN RECEIVED. DEVICE EVALUATION BY THE TECHNICIAN FOR SERVICING HAS NOT YET BEEN COMPLETED. PER THE INSTRUCTIONS FOR USE (IFU) ¿A THOROUGH INSPECTION OF EQUIPMENT SHOULD BE PERFORMED, AFTER EACH SERVICE CALL, PRIOR TO RELEASING THE EQUIPMENT FOR USE.¿ ADDITIONALLY, ¿THE ZERO-GRAVITY SYSTEM REQUIRES ANNUAL PREVENTATIVE MAINTENANCE, INSPECTION, AND GENERAL CLEANING THROUGHOUT ITS LIFE.¿ MANUFACTURER REFERENCE FILE (B)(4).

    Description of Event or Problem · 0

    MONORAIL SCREW COVERS FALLING INTO STERILE FIELD. MODEL: ZGCH. SERIAL#: (B)(4). MANUFACTURED 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902436 ZERO GRAVITY CONTOUR TRACK SYSTEM APRON, LEADED EAJ TIDI PRODUCTS LLC ZGCH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown