BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO GRAVTY FLOOR SYSTEM 6.5' ARM

    MDR report key: 16296618 · Received February 3, 2023

    Report

    Report Number
    2182318-2023-00003
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 11, 2023
    Report Date
    February 3, 2023
    Manufacturer
    TIDI PRODUCTS LLC
    Product Code
    EAJ
    UDI-DI
    00618125176250
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS INITIALLY REPORTED TO THE DISTRIBUTOR, BIOTRONIK. IT WAS REPORTED ON (B)(6) 2023, THAT THE STOP BLOCK WHICH HOLDS THE BOOM ARM IN PLACE BROKE DURING A CASE. THE BLOCK IS HELD ON BY 2 ALLEN BOLTS AND WAS BROKEN, ONE OF THE BOLTS HAD SHEARED OFF. BIOMEDICAL ENGINEERING REMOVED THE BLOCK FROM THE UNIT COMPLETELY. WHILE THE UNIT WAS BEING MOVED OUT OF THE LAB FOR REPAIR, THE BOOM ARM SWUNG 180 DEGREES, SHIFTING THE WEIGHT OF THE UNIT AND IT TIPPED OVER. A TECHNICIAN WHO WAS INVOLVED IN THE CASE INTERVENED ATTEMPTING TO CUSHION THE FALL AND STRAINED HER BACK. UPON FOLLOW-UP A WEEK LATER, IT WAS REPORTED THAT THE TECHNICIAN WAS OKAY AND HAD RETURNED TO WORK. THE ORIGINAL FAILURE OF THE STOP BLOCK WAS NOT REPORTED TO TIDI (MANUFACTURER) OR BIOTRONIK (DISTRIBUTOR). AN UNAUTHORIZED REPAIR WAS COMPLETED BY BIOMEDICAL ENGINEERING AT THE USER FACILITY AND THE DEVICE WAS RETURNED TO USE. UPON MANUFACTURER AWARENESS OF THE EVENT, THE USER FACILITY WAS INSTRUCTED NOT TO USE THE DEVICE UNTIL A COMPANY REPRESENTATIVE CAN REVIEW THE UNIT. UNIT WAS REVIEWED ON JANUARY 24, 2023 BY A TRAINED TECHNICIAN AND RETURNED TO OEM STANDARDS. ROOT CAUSE FOR THE ORIGINAL FAILURE IS UNKNOWN. THE UNIT WAS MANUFACTURED IN 2019. THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. PER THE INSTRUCTIONS FOR USE (IFU) ¿THE FLOOR UNIT MAY BE MOVED TO OTHER ROOMS IF DISASSEMBLY IS NOT REQUIRED. IF DISASSEMBLY IS REQUIRED, CONTACT TIDI PRODUCTS SERVICE.¿ ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE: (B)(4).

    Description of Event or Problem · 0

    INFORMED VIA PHONE CALL BY THE BIOTRONIK DISTRIBUTOR THE FOLLOWING INFORMATION: ORIGINAL PRODUCT FAILURE WAS NOT REPORTED TO TIDI OR BIOTRONIK - POSSIBLE BROKEN SCREW IN STOP BLOCK. REPAIRED PERFORMED BY CUSTOMER BIOMED. WHILE MOVING THE UNIT BEFORE OR AFTER THE REPAIR, IT FELL OVER. THE PERSON DOING THE MOVING OF SYSTEM HAS REPORTED A SORE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082145 ZERO GRAVTY FLOOR SYSTEM 6.5' ARM APRON, LEADED EAJ TIDI PRODUCTS LLC ZGM-6-5H 624523 00618125176250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other