BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D 860 - CFK - POLYMER

    MDR report key: 6337675 · Received February 16, 2017

    Report

    Report Number
    0008010153-2017-00011
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 31, 2017
    Report Date
    February 16, 2017
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY LOCKS DOWN AND THE ACCOUNT WAS STILL ABLE TO REST AGAINST TABLE AND IT WOULD MOVE. THE BIOMED ALSO REPORTED THAT THE OPERON (B)(4) FOOT PADS ARE MISSING AND THE TABLE MOVES. THE FLOOR LOCK CYLINDERS WERE REPLACED AND THE TABLE WAS RETURNED TO THE CUSTOMER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE ALLEGEDLY LOCKS DOWN AND THE ACCOUNT WAS STILL ABLE TO REST AGAINST TABLE AND IT WOULD MOVE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120050 D 860 - CFK - POLYMER TABLE, OPERATING-ROOM, ELECTRICAL GDC BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1