BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYTRON

    MDR report key: 6043871 · Received October 20, 2016

    Report

    Report Number
    1825014-2016-00010
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    August 31, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MIZUHO MEDICAL CO., LTD
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED ON 8/31/2016 VIA MAIL. HOWEVER, WE THEN RECEIVED A MESSAGE FROM THE FDA THAT ALL REPORTS THEN HAD TO BE SUBMITTED ELECTRONICALLY. IT TOOK A FEW WEEKS TO GET OUR PRODUCTION ACCOUNT UP AND RUNNING WHICH CAUSED THE DELAY IN REPORTING.

    Description of Event or Problem · 1

    DURING A CASE THE TABLE COLLAPSED ON ONE SIDE, THE PATIENT'S RIGHT SIDE AND THE PATIENT SLID TO THE FLOOR. THE PATIENT WAS NOT INJURED. FACILITY: (B)(6). THIS TABLE ALLEGEDLY "FUNCTIONED/ MOVED" ON ITS OWN ALLOWING A PATIENT TO FALL OFF THE TABLE. CASE ID: (B)(4). CONTACT NOTES: AFTER SEVERAL ATTEMPTING TO CONTACT (B)(6) I WAS FINALLY ABLE TO TALK WITH HER ON (B)(6) 2016 AT 1255 PM. (B)(6) HAD ASKED IF I WOULD SEND SOMEONE FORM SKYTRON CORPORATE TO INSPECT THE TABLE. I ADVISED HER THAT WHEN A TABLE IS INVOLVED WITH AN ISSUE LIKE THIS WE WOULD RATHER HAVE THE TABLE SHIPPED TO SKYTRON FOR A DEEP DIVE INVESTIGATION. SHE STATED THAT SHE WOULD NEED TO SEEK APPROVAL FOR THIS AS SHE WAS DIRECTED TO SEQUESTER THE TABLE. I ADVISED HER THAT IF SHE COULD NOT ATTAIN THE APPROVAL THAT I WOULD SEND A TECHNICIAN ON SITE FOR AN INITIAL DIAGNOSIS INSPECTION BUT THIS WOULD NOT BE AS DETAILED AS IF THE TABLE WAS AT SKYTRON, SHE SAID SHE UNDERSTOOD. THEN SHE SHARED WITH ME THAT THEY HAD CONCERNS ABOUT A RECENT REPAIR IN JUNE. SHE MENTIONED THAT ONE OF THE FACILITY STAFF HAD SEEN THE SKYTRON DISTRIBUTOR TECHNICIAN AT A CERTAIN STAGE OF THE REPAIR AND THAT THEY HAD THE TABLE IN SEVERAL PIECES AND THAT THE FACILITY IS CONCERNED THAT THIS MAY HAVE CONTRIBUTED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695400 SKYTRON OPERATING TABLE FQO MIZUHO MEDICAL CO., LTD 3002

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention