BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDANIC FOR D650 AC 3-POLE

    MDR report key: 6204716 · Received December 27, 2016

    Report

    Report Number
    0001220865-2016-00022
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 27, 2016
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE LIGHT HEAD ALLEGEDLY FELL. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED FOR INVESTIGATION. WHEN THE SFST ARRIVED TO THE CUSTOMER SITE, THE LIGHT HEAD WAS DISCONNECTED FROM THE CARDANIC AND WAS LAYING ON THE SURGICAL TABLE. THE SFST NOTED THAT THE FOUR SCREWS THAT HELD THE LIGHT HEAD IN PLACE BECAME LOOSE, RESULTING IN THE SEPARATION. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT HEAD ALLEGEDLY FELL. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856779 CARDANIC FOR D650 AC 3-POLE SURGICAL LIGHT FSY BERCHTOLD CORP

    Patients

    Seq Age Sex Outcome Treatment
    1