BEUDAMED
    FDA Adverse Event Summary report: N

    5803, ADVANCED CONTROL BASE MODULAR TABLE BASE

    MDR report key: 2573246 · Received March 26, 2012

    Report

    Report Number
    2921578-2012-00003
    Date Received
    March 26, 2012
    Date of Event
    March 8, 2012
    Report Date
    March 19, 2012
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL FROM THE HOSPITAL WAS NOTED, AS A PATIENT RELATED EVENT. THE DEVICE WAS EVALUATED AND DETERMINED TO REQUIRE MUCH NEEDED REPAIR. THE HOSPITAL STATED THAT ALL REPAIRS WERE COMPLETED BY THEIR SERVICE PROVIDER KNOWN AS (B)(4), THE HOSPITAL ORDERED NEW BATTERIES, BASE PLATE TROLLEY AND CAM FOLLOWER BEARINGS FOR THE TABLE'S MECHANICAL SYSTEM. A PREVENTATIVE MAINTENANCE WAS REQUESTED BY MIZUHO OSI PERSONNEL AND THE HOSPITAL AGREED THAT IT WOULD BE BEST IF THE REPAIR WAS COMPLETED BY MIZUHO OSI.

    Description of Event or Problem · 1

    THE TABLE WAS BROUGHT INTO SURGERY AND THE BATTERY WAS DEAD (NO LIGHTS). WHEN THE TABLE WAS PLUGGED IN, IT WAS STILL NOT FUNCTIONING. WITH PATIENT ON THE TABLE, THE STAFF UNLOCKED THE SAFETY LOCKS AND ATTEMPTED TO ROTATE TABLE; HOWEVER, THEY HAD FAILED TO ENSURE THE PATIENT WAS PROPERLY SECURED TO THE TABLE WITH THE PATIENT SAFETY STRAPS. THIS FAILURE CAUSED THE PATIENT TO FALL FROM THE TABLE DURING ROTATION. NO INJURY WAS REPORTED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5803, ADVANCED CONTROL BASE MODULAR TABLE BASE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO OSI 5803 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK