BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHT HEAD E 668 NC W/O PAD

    MDR report key: 5328838 · Received December 28, 2015

    Report

    Report Number
    0001220865-2015-00010
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    December 2, 2015
    Report Date
    December 2, 2015
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A LIGHTHEAD ALLEGEDLY FELL OFF OF A SPRING ARM. THIS OCCURRED AFTER A CASE AND DURING CLEAN UP. A STRYKER FIELD SERVICE TECHNICIAN (SFST) EVALUATED THE ISSUE AND FOUND THAT THE BRAKE SCREWS WERE LOOSE. THE SFST FIXED THE ISSUES AND ALL FUNCTIONS WERE NORMAL. NO ADVERSE EVENTS OR INJURIES WERE REPORTED. A SUPPLEMENTAL MDR WILL BE FILED IF DEEMED NECESSARY PENDING CONCLUSION OF THE STRYKER QUALITY ENGINEER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AN E668 LIGHT HEAD FELL FROM THE SPRING ARM. THIS OCCURRED AFTER A CASE DURING CLEAN UP. THE LIGHT HEAD DID NOT FALL TO THE GROUND, IT WAS CAUGHT BY INTERNAL WIRING. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES. WHEN THE BIOMED AT THE SITE EXAMINED THE STATE OF THE EQUIPMENT, HE DETERMINED THE RETAINING SCREW AND THE BRAKE SCREW WERE BOTH PARTIALLY BACKED OUT. THE ROOT CAUSE OF THIS FAILURE IS BELIEVED TO BE CUSTOMER MISUSE IN REMOVING THESE SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGHTHEAD ALLEGEDLY FELL OFF OF A SPRING ARM. THIS OCCURRED AFTER A CASE AND DURING CLEAN UP. NO ADVERSE EVENTS OR INJURIES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGHTHEAD ALLEGEDLY FELL OFF OF A SPRING ARM. THIS OCCURRED AFTER A CASE AND DURING CLEAN UP. NO ADVERSE EVENTS OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854271 LIGHT HEAD E 668 NC W/O PAD CHROMOPHARE E668 FSY BERCHTOLD CORP

    Patients

    Seq Age Sex Outcome Treatment
    1