BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS ZERO-GRAVITY

    MDR report key: 6156892 · Received December 8, 2016

    Report

    Report Number
    1825560-2016-00003
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    EAJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    BODY SHIELD FRAME TUBE SLIPPED OUT OF THE CLAMP BLOCK DUE TO ALL FOUR CLAMP BOLTS BEING LOOSENED. THE HOSPITAL REPORTS THAT THEY DID NOT LOOSEN THE FOUR BOLTS, BUT TIDI PRODUCTS BELIEVES THAT SOMEHOW THOSE BOLTS HAD TO HAVE BEEN LOOSENED NOT LONG BEFORE THE INCIDENT. THE ORIGINAL INSTALLER REPORT INDICATES THAT THE BOLTS WERE TIGHT AT INSTALLATION, THE HISTORY OF >400 OTHER INSTALLATIONS SEEMS TO INDICATE THAT THE BOLTS WILL NOT LOOSEN RANDOMLY OR DUE TO SOME OTHER INFLUENCE, AND THE BEHAVIOR OF THE SYSTEM IS SUFFICIENTLY DIFFERENT WITH THE BOLTS LOOSE THAT WE ARE CONFIDENT THEIR LOOSE STATUS WOULD HAVE BEEN NOTICED BY USERS IF IT HAD PERSISTED FOR LONG BEFORE THE INCIDENT. OUR WORKING THEORY IS THAT SOMEONE ASSOCIATED WITH THE HOSPITAL MAY HAVE LOOSENED THE BOLTS SO AS TO REMOVE THE BODY SHIELD FOR PERIODIC FLUOROSCOPIC RADIATION-SHIELD CHECKING (I.E. STATE LAW REQUIREMENT), THEN FAILED TO FULLY RE-TIGHTEN THEM UPON RE-HANGING THE BODY SHIELD. NOTE THAT THIS MEANS OF FLUOROSCOPING THE BODY SHIELD IS CONTRARY TO THE PROCEDURE DETAILED IN THE USER MANUAL. COINCIDENTALLY, TIDI PRODUCTS' PRODUCT REPRESENTATIVE (B)(6) WAS ON HIS WAY TO THE HOSPITAL THAT DAY, AND LEARNED OF THE ISSUE UPON ARRIVAL. SO, HE PROPERLY RE-INSTALLED THE BODY SHIELD WITH TIGHTENED BOLTS. NOTE THAT THERE WAS NO CABLE BREAKAGE OR OTHER ISSUE THAT MIGHT BE RELATED TO CABLE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807427 TIDI PRODUCTS ZERO-GRAVITY RADIATION SHIELD SYSTEM EAJ TIDI PRODUCTS, LLC ZGCM-HSA 575365

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR