BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLI-C, FOOTREST

    MDR report key: 13318352 · Received January 21, 2022

    Report

    Report Number
    1000188474-2021-00001
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    August 30, 2021
    Report Date
    September 30, 2021
    Manufacturer
    NRT X-RAY A/S
    Product Code
    OWB
    UDI-DI
    05713464000336
    PMA / PMN Number
    K173631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT TOOK PLACE AT A HOSPITAL IN (B)(6) BUT SINCE THE DEVICE INVOLVED IS ALSO MARKETED IN THE US, WE DECIDED TO REPORT THIS TO THE FDA. THE FOOTREST FROM THE SITE IS BEING INVESTIGATED. FROM THE INFORMATION AVAILABLE, WE CAN CONCLUDE THAT THE FRICTION RUBBER STRIP ON ONE SIDE OF THE FOOTREST COMPRESSION MECHANISM FELL OFF BEFORE THE OPERATOR LOCKED THE FOOTREST INTO PLACE ON THE PATIENT TABLE, AS THE RUBBER WAS FOUND ON THE FLOOR. THE FOOTREST DID NOT FALL TO THE FLOOR AS IT WAS HELD IN PLACE BY THE FRICTION RUBBER ON THE OPPOSITE SIDE OF THE PATIENT TABLE WHICH WAS ABLE TO CARRY THE WEIGHT OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOOTREST SLID DOWN ALONG THE PATIENT TABLE WHILE IN USE WITH A PATIENT. THE PATIENT GRABBED THE PATIENT TABLE AND DID NOT FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390437 INTELLI-C, FOOTREST INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM  OWB NRT X-RAY A/S 03282000 05713464000336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other