BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMOPHARE

    MDR report key: 7577421 · Received June 7, 2018

    Report

    Report Number
    7577421
    Event Type
    Malfunction
    Date Received
    June 7, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 31, 2018
    Manufacturer
    STRYKER COMMUNICATIONS, INC
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OR OPERATING LIGHT IN THE ROOM IS DRIFTING SO MUCH, THAT A MEDICAL STUDENT HAD TO HOLD IT STILL WHILE SURGEON OPERATED. WE THEN STABILIZED IT AGAINST AN EXTRA IV POLE HOWEVER THIS IS A CONTINUING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419085 CHROMOPHARE DEVICE, MEDICAL EXAMINATION, AC POWERED KZF STRYKER COMMUNICATIONS, INC D650P

    Patients

    Seq Age Sex Outcome Treatment
    1