BEUDAMED
    FDA Adverse Event Other Summary report: N

    HANAULUX 2003 LIGHT

    MDR report key: 21129 · Received January 24, 1995

    Report

    Report Number
    2919178-1995-00002
    Event Type
    Other
    Date Received
    January 24, 1995
    Date of Event
    October 17, 1994
    Report Date
    March 17, 1995
    Manufacturer
    HERAEUS INSTRUMENTS
    Product Code
    FQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FOLLOW-UP REPORT 2/17/95DURING A FIELD SERVICE VISIT, IT WAS DETERMINED THAT THE OPERATING ROOM LIGHTHEADS WERE LONDON LIGHTS, MOUNTED ON A MODEL 22000 SERIES SPRING ARM. THE LIGHT ASSEMBLY WAS INSTALLED BY A PREVIOUS DISTRIBUTOR. THE RETAINING COLLAR WAS FOUND TO BE IN THE UP POSITION, WHICH ALLOWED THE CLIP TO COME OUT AND THE LIGHT HEAD TO FALL. THE RETAINING CLIP WAS NOT RETREIVED.THE HOSPITAL REPORTED THAT THE PT WAS UNINJURED, HOWEVER THE NURSE WAS HIT ON THE FACE IN AN AREA WHERE SHE HAD BEEN PREVIOUSLY INJURED DURING AN UNRELATED INCIDENT. NO FURTHER DETAILS OF THE EXTENT OF THE NURSES INJURY WERE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANAULUX 2003 LIGHT OPERATING ROOM LIGHT FQP HERAEUS INSTRUMENTS 2003 0288007

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other