BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODULAR TABLE

    MDR report key: 2623699 · Received May 18, 2012

    Report

    Report Number
    2921578-2012-00006
    Event Type
    Other
    Date Received
    May 18, 2012
    Date of Event
    March 28, 2012
    Report Date
    May 1, 2012
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE REQUESTED ADD¿L INFO FROM THE DISTRIBUTOR ON THIS INCIDENT (E.G. PROCEDURE, SURGICAL DURATION, PROCESS, PT MONITORING, USE OF PAD COVERS, ADD¿L COMPONENTS USED, AND POSITIONING OF PT) THE DISTRIBUTOR HAS RESPONDED STATING THAT THE PT WAS PRONE, THE HEALTHCARE FACILITY USED ADD¿L NON-MIZUHO OSI GEL PADS OVER THE HIP COVERS. THE GEL WAS INITIALLY CHECKED TO ENSURE IT WAS SMOOTH; HOWEVER, OVER A TWO HOUR SPAN 2-3 POUNDS WERE ADDED EVERY 5-7 MINUTES FOR A TOTAL OF ALMOST 100 POUNDS. THE PT WAS MONITORED EVERY 1 ½ HOURS HOWEVER, THEY COULD NOT MONITOR THE PRESSURE POINTS AS THEY COULD NOT CHANGE THE PT¿S POSITION. THE HOSPITAL STATED THAT IF THEY MOVED THE PT, ADD¿L X-RAYS WOULD BE NEEDED. WE HAVE CONTACTED THE HOSP TO INFORM THEM THAT REGARDLESS OF THE ADD¿L FRAMES AND WEIGHTS, PT MONITORING IS REQUIRED AS IT IS NECESSARY TO ENSURE PT SAFETY. BECAUSE THE DECISIONS OF USE WERE DEEMED ACCEPTABLE BY THE CLINICIAN AND WEIGHTED AGAINST ANY OTHER POSSIBLE OUTCOMES WE ARE CLOSING THIS COMPLAINT.

    Description of Event or Problem · 1

    PT UNDERGOING 12 HOUR SPINAL OPERATION FOR SCOLIOSIS ON THE MODULAR TABLE SYSTEM EXPERIENCED BLISTERING FROM PRESSURE POINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR TABLE OPERATING ROOM TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR