BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMOPHARE

    MDR report key: 2121452 · Received May 6, 2011

    Report

    Report Number
    1220685-2011-00002
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EVALUATED BY A BERCHTOLD SERVICE REP ON-SITE. THE SCREW THAT HOLDS THE COVER WHICH KEEPS THE LAMPHEAD RETAINER IN PLACE WAS MISSING. THE COVER WAS ROTATED AROUND TO THE POINT WHERE THE LAMPHEAD RETAINER, WHICH HOLDS THE LAMPHEAD IN THE SPRING ARM, FELL OUT, ALLOWING THE LAMPHEAD TO DISCONNECT FROM THE SPRING ARM AND FALL OUT OF THE SPRING ARM. THE LAMPHEAD RETAINER WAS FOUND ON THE FLOOR BY FACILITY PERSONNEL AND WAS TAPED TO THE LAMPHEAD. NO PREVENTATIVE MAINTENANCE RECORDS WERE AVAILABLE FOR THE LIGHTS, WHICH ARE NOT MAINTAINED BY BERCHTOLD PERSONNEL, AND THE BERCHTOLD SVC REP WAS TOLD THAT THE LIGHTS ARE NOT ON ANY TYPE OF PM SCHEDULE. THE BERCHTOLD REP RE-INSTALLED THE LAMPHEAD, THE RETAINER, ALIGNED THE COVER, AND INSTALLED A NEW COVER SCREW. THE LAMPHEAD WAS CHECKED TO BE FUNCTIONING SATISFACTORILY. THE CUSTOMER WILL PLACE THE LIGHTS ON A BERCHTOLD RECOMMENDED PM SCHEDULE.

    Description of Event or Problem · 1

    DURING A PROCEDURE IN THE OPERATING ROOM, THE LAMPHEAD WAS MOVED BY A MEMBER OF THE SURGICAL TEAM, AND FELL OFF OF THE SPRING ARM. THE LAMPHEAD WAS CAUGHT BY A MEMBER OF THE SURGICAL TEAM, BUT STRUCK THE PT IN THE ARM. NO INJURY RESULTED FROM THIS PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL LIGHT FQP BERCHTOLD CORP. D 530

    Patients

    Seq Age Sex Outcome Treatment
    1