BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 851365 · Received May 15, 2007

    Report

    Report Number
    1220685-2007-00002
    Event Type
    Other
    Date Received
    May 15, 2007
    Date of Event
    April 18, 2007
    Report Date
    May 7, 2007
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: UPON INVESTIGATION, IT WAS CONCLUDED THAT THE LIGHT WAS IMPROPERLY INSTALLED INITIALLY BY AN OUTSIDE CONTRACTOR. THE LIGHT WAS FOUND WITH AN IMPROPERLY POSITIONED SNAP RING IN THE SUSPENSION ARM. BERCHTOLD OFFERS A PRE-INSTALL MANUAL FOR THIS SERIES LIGHT WHICH CAN BE DOWNLOADED VIA BERCHTOLD'S WEBSITE. IT IS UNK IF THE CONTRACTOR USED THIS MANUAL DURING INSTALL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE LIGHT "FELL APART" WHILE A NURSE WAS MOVING THE LIGHT. NO INJURIES WERE REPORTED AS A RESULTS OF THIS INCIDENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR