BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELETOM 700 SERIES

    MDR report key: 490539 · Received October 17, 2003

    Report

    Report Number
    1220685-2003-00004
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    September 16, 2003
    Report Date
    October 13, 2003
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL PERSONNEL WERE CLEANING AN OPERATING ROOM AFTER A CASE, WHEN A BOOM LINKAGE BROKE AND SHIFTED THE BOOM DOWNWARD UNTIL THE GAS SPRINGS ENGAGED. THE HOSPITAL EMPLOYEE WAS POSITIONED IN FRONT OF THE ROOM WHEN IT SHIFTED DOWNWARD. THE DOWNWARD SHIFT REPORTEDLY DISLODGED A BOVIE, AN APPROXIMATELY TEN POUND PIECE OF EQUIPMENT LOADED ON THE BALLOON SHELF, WHICH STRUCK THE EMPLOYEE ON THE TOE. THE EQUIPMENT WAS NOT STRAPPED DOWN AS INSTRUCTED IN THE OPERATING MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELETOM 700 SERIES POWER BOOM FQO BERCHTOLD CORP. 720 SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other