BEUDAMED
    FDA Adverse Event Death Summary report: N

    SKYTRON

    MDR report key: 893447 · Received August 7, 2007

    Report

    Report Number
    1825014-2007-00010
    Event Type
    Death
    Date Received
    August 7, 2007
    Date of Event
    July 31, 2007
    Report Date
    August 6, 2007
    Manufacturer
    MIZUHO MEDICAL CO., LTD
    Product Code
    BWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SKYTRON SENT THE LOCAL DISTRIBUTOR TO THE FACILITY TO ASSESS THE SITUATION. HE RECEIVED CONFLICTING INFORMATION FROM THE MEDICAL STAFF IN THE OR. WE WILL CONTINUE TO MONITOR THE SITUATION AND SEND THE FDA UPDATES AS WE RECEIVE THEM.

    Description of Event or Problem · 1

    A PATIENT, HAD AN OPEN HEART SURGERY PROCEDURE WITH PATIENT REVERSED ON THE TABLE. PATIENT'S CHEST BEGAN TO FILL WITH FLUID, SO THE ANESTHESIOLOGIST PUT TABLE IN REVERSE TRENDELENBURG POSITION. ACCORDING TO THE STAFF, THE TABLE BEGAN TO TIP TOWARDS ANESTHESIA. WHILE ATTEMPTING TO PREVENT THE PATIENT FROM FALLING, TWO MALE STAFF MEMBERS LEANED ON TABLE AND GRABBED PATIENT. THE PATIENT WAS NOT RESTRAINED WHILE ON THE TABLE AND NOBODY SAW THE FEET OF THE TABLE ACTUALLY LIFT OFF THE FLOOR. THE INCIDENT OCCURRED AT: THE MEDICAL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKYTRON SURGICAL TABLE BWN MIZUHO MEDICAL CO., LTD 3600B

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death