BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5803 ADVANCED CONTROL BASE

    MDR report key: 2142564 · Received June 20, 2011

    Report

    Report Number
    2921578-2011-00016
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 12, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MIZUHO OSI
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY AS PATIENT HAD JUST GOT ONTO TABLE. UPON REVIEW, IT WAS NOTED THAT THE DEVICE HAD NOT BEEN MAINTAINED, THE BATTERIES WERE DEAD, AND THE TABLE'S LOCKING MECHANISM WAS OUT OF ADJUSTMENT. THE TABLE WAS ADJUSTED, AND THE CUSTOMER WAS INFORMED THAT THE BATTERIES WERE REQUIRED TO BE REPLACED. TO DATE, THE CUSTOMER HAS NOT ORDERED REPLACEMENT BATTERIES FROM MIZUHO (B)(4). THE CUSTOMER WAS NOTIFIED OF THE REQUIREMENT AND OF ITS IMPORTANCE TO THE FUNCTIONALITY OF THE TABLE.

    Description of Event or Problem · 1

    OUR INDEPENDENT SERVICE REPAIR REPRESENTATIVE WAS REQUESTED TO REVIEW A TABLE. AFTER HIS REVIEW, HE WAS INFORMED THAT THE HOSPITAL HAD DROPPED A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5803 ADVANCED CONTROL BASE OPERATING ROOM TABLE GDC MIZUHO OSI 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other