BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CONTROL BASE

    MDR report key: 8903601 · Received August 16, 2019

    Report

    Report Number
    2921578-2019-00032
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    August 12, 2019
    Report Date
    September 18, 2019
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO OPERATOR ERROR OF NOT STRAPPING PATIENT TO TABLE, THIS DIRECTLY CONTRIBUTED TO THE PATIENT FALLING OFF OF THE TABLE. THERE IS ALSO CONCERN WITH LACK OF SERVICE ON THE TABLE, AS MIZUHO OSI SERVICE RECORDS SHOW NO SERVICE ACTIVITY ON THIS TABLE SINCE IT WAS PURCHASED. ADDITIONALLY, THE SITE DOES NOT HAVE ANY TRAINED AND CERTIFIED PERSONNEL TO SERVICE THE TABLE, SO IT IS UNKNOWN WHAT THE SERVICE ACTIVITY HISTORY IS FOR THIS TABLE.

    Additional Manufacturer Narrative · 0

    PMA/510K: CORRECTED INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN THEY WERE TILTING THE TABLE, THE TABLE SLIPPED WHICH CAUSED THE PATIENT TO FALL OF THE TABLE. PATIENT WAS NOT STRAPPED TO THE TABLE TOP. UPDATE INFORMATION: PATIENT WAS NOT SECURED BY THE STRAP ON TABLE; MAY HAVE A POSSIBLE CONCUSSION FROM FALL TRANSFERRED TO ANOTHER HOSPITAL

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN THEY WERE TILTING THE TABLE, THE TABLE SLIPPED WHICH CAUSED THE PATIENT TO FALL OF THE TABLE. PATIENT WAS NOT STRAPPED TO THE TABLE TOP. UPDATE INFORMATION: PATIENT WAS NOT SECURED BY THE STRAP ON TABLE; MAY HAVE A POSSIBLE CONCUSSION FROM FALL TRANSFERRED TO ANOTHER HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE OCCURRENCES OF REDNESS/SKIN BREAKDOWN ON PATIENTS UNDERGOING PRONE SURGERY DURING MARCH 2019 TO JULY 2019. SECOND MDR 2921578-2019-00030 WAS CREATED TO REPORT THE SECOND PATIENT, AS THIS EVENT OCCURRED ON AT LEAST 2 PATIENTS. NO INFORMATION ABOUT THE SEVERITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696058 ADVANCED CONTROL BASE SURGICAL OPERATING TABLE JEA MIZUHO ORTHOPEDIC SYSTEMS, INC. 5803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other