BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR TABLE SYSTEM CHEST PLATE

    MDR report key: 6632107 · Received June 9, 2017

    Report

    Report Number
    2921578-2017-00004
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    November 11, 2016
    Report Date
    August 30, 2017
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO FULLY INVESTIGATE AND EVALUATE ALLEGED PRODUCT FAILURE DUE TO CHEST PLATE SUPPORT ASSEMBLY NOT SENT BACK TO MIZUHO OSI. IN REVIEWING IMAGES SENT, WITHOUT PHYSICALLY HAVING THE PART IN OUR HANDS WE ARE UNABLE TO DETERMINE THE CAUSE. MIZUHO OSI SERVICE HAS NO RECORD OF ANY ON-SITE SERVICE ACTIVITY BY A TRAINED/CERTIFIED MIZUHO OSI FIELD SERVICE TECHNICIAN FOR THIS TABLE. TABLE WAS SERVICED BY GE HEALTHCARE TECHNICIAN WHO IS NOT TRAINED OR CERTIFIED BY MIZUHO OSI TO SERVICE OUR TABLES.

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, A POPPING NOISE WAS HEARD; THE CHEST PLATE OF THE JACKSON OR TABLE BROKE. THE PATIENT WAS PRONE ON THE TABLE. THIS RESULTED IN INCREASED PRESSURE EXERTED ON THE PATIENT'S CHEST AND FACE. THE PATIENT HAD A REDDENED AREA ON HIS CHEST THAT RESOLVED. APPROXIMATELY 3 WEEKS LATER, THE PATIENT REPORTED LIMITED JAW RANGE OF MOTION.

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, A POPPING NOISE WAS HEARD; THE CHEST PLATE OF THE JACKSON OR TABLE BROKE. THE PATIENT WAS PRONE ON THE TABLE. THIS RESULTED IN INCREASED PRESSURE EXERTED ON THE PATIENT'S CHEST AND FACE. THE PATIENT HAD A REDDENED AREA ON HIS CHEST THAT RESOLVED. APPROXIMATELY 3 WEEKS LATER, THE PATIENT REPORTED LIMITED JAW RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411528 MODULAR TABLE SYSTEM CHEST PLATE CHEST SUPPORT JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5840-580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other