BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NC 1 CM/WITH OPMI: CS NC

    MDR report key: 217939 · Received April 1, 1999

    Report

    Report Number
    2431026-1999-00001
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Date of Event
    February 22, 1999
    Report Date
    March 24, 1999
    Manufacturer
    CARL ZEISS, INC.
    Product Code
    FSY
    Removal / Correction Number
    NOT RECEIVED YET
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE BEGINNING OF A PROCEDURE IN THE OPERATING ROOM, THE STAFF MOVED THE NC 1 CEILING MOUNT INTO THE FIELD. AFTER MOVING IT A LIGHT WAS NOT OPERATIONAL; THEY MOVED IT AWAY TO CHECK IT AND THE UNIT FELL. NO ONE WAS DIRECTLY HIT, BUT A NURSE ALLEGEDLY SUFFERED A MINOR INJURY AS THE UNIT ROLLED ON THE FLOOR. THIS UNIT WAS A CONVERTED FLOOR STAND THAT REQUIRED A PIN TO STOP THE CLUTCH/SCREW FROM BACKING OUT. THE PIN WAS NOT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NC 1 CM/WITH OPMI: CS NC CEILING MOUNT SUSPENSION SYSTEM FSY CARL ZEISS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *