BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTHEAD F628 W/O CARDANIC

    MDR report key: 5632860 · Received May 4, 2016

    Report

    Report Number
    0001220865-2016-00013
    Event Type
    Malfunction
    Date Received
    May 4, 2016
    Date of Event
    April 1, 2016
    Report Date
    April 5, 2016
    Manufacturer
    BERCHTOLD GMBH & CO. KG
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT LIGHT NUMBER 1 WOULD NOT WORK. UPON ARRIVAL AND VISUAL INSPECTION, IT WAS FOUND THAT THE SHOULDER SCREW WAS MISSING FROM THE LOCK BUSHING. THERE ARE 3 LIGHTS IN THE ROOM THAT WERE INSTALLED AT THE SAME TIME, THEREFORE, THE TECHNICIAN LOOKED AT THE TWO ADDITIONAL LIGHTS AND FOUND THE SAME MISSING SHOULDER SCREW. THE INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL WILL BE FILED UPON COMPLETION. THERE WERE NO INJURY OR ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    STRYKER COMMUNICATIONS WAS DISPATCHED TO THE SITE TO INVESTIGATE THIS ISSUE. DURING THE INVESTIGATION, THE STRYKER FIELD SERVICE TECHNICIAN (SFST) DISCOVERED THAT THE ROOT CAUSE OF THE POWER LOSS WAS THAT THE LIGHT WAS SEPARATING FROM THE SPRING ARM. FURTHER INVESTIGATION REVEALED THAT THE SET SCREW, WHICH IS USED TO SECURE THE LIGHT TO THE SPRING ARM, WAS MISSING. THE TECHNICIAN INSTALLED THE SET SCREW ON THE LIGHT, PERFORMED FUNCTIONAL TESTING, AND FOUND THE LIGHT WAS FUNCTIONING PROPERLY. THE ROOM WAS THEN PLACED BACK INTO SERVICE, AND THE ISSUE WAS RESOLVED. THE ORIGINAL MDR STATED THE PRODUCT AS A CHROMOPHARE F628/F528 US OPERATOR AND THE INVESTIGATION REVEALED THE CORRECT PART NUMBER TO BE A LIGHTHEAD F628 W/O CARDANIC. THE SERIAL NUMBER WAS STATED AS UNKNOWN AND THE INVESTIGATION REVEALED IT TO BE (B)(4). THE CHROMOPHARE F628/F528 US OPERATOR WAS REPORTED TO BE MANUFACTURED BY BERCHTOLD CORP AND HAS BEEN UPDATED AS BEING MANUFACTURED BY BERCHTOLD (B)(4) & CO. KG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIGHT NUMBER 1 WOULD NOT WORK. UPON ARRIVAL AND VISUAL INSPECTION, IT WAS FOUND THAT THE SHOULDER SCREW WAS MISSING FROM THE LOCK BUSHING. THERE ARE 3 LIGHTS IN THE ROOM THAT WERE INSTALLED AT THE SAME TIME, THEREFORE, THE TECHNICIAN LOOKED AT THE TWO ADDITIONAL LIGHTS AND FOUND THE SAME MISSING SHOULDER SCREW. THERE WAS NO PATIENT INVOLVEMENT, INJURIES OR ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LIGHT NUMBER 1 WOULD NOT WORK. UPON ARRIVAL AND VISUAL INSPECTION, IT WAS FOUND THAT THE SHOULDER SCREW WAS MISSING FROM THE LOCK BUSHING . THERE ARE 3 LIGHTS IN THE ROOM THAT WERE INSTALLED AT THE SAME TIME, THEREFORE, THE TECHNICIAN LOOKED AT THE TWO ADDITIONAL LIGHTS AND FOUND THE SAME MISSING SHOULDER SCREW. THERE WAS NO PATIENT INVOLVEMENT, INJURIES OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287777 LIGHTHEAD F628 W/O CARDANIC SURGICAL LIGHT FSY BERCHTOLD GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1