BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED CONTROL I-BASE, DC

    MDR report key: 17786399 · Received September 20, 2023

    Report

    Report Number
    2921578-2023-00015
    Event Type
    Injury
    Date Received
    September 20, 2023
    Date of Event
    August 2, 2023
    Report Date
    October 17, 2023
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430106026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION OBTAINED FROM INVESTIGATION, THE TABLE DID NOT HAVE ANY FUNCTIONAL ISSUES. IT WAS FOUND THE FOOT END COLUMN WAS UNLOCKED AND TABLE HAD SOME INSTABILITY. THE PATIENT SWUNG OUT AND FELL TO THE FLOOR. AN IN-SERVICE TRAINING WAS PERFORMED BY MIZUHO OSI PERSONNEL FOR HOSPITAL STAFF ON PROPER USE OF THE TABLE AND ENSURING THAT BOTH HEAD AND FOOT ENDS ARE LOCKED.

    Additional Manufacturer Narrative · 0

    THE MANUAL EXPLAINS THE OPERATION OF THE HEAD-END AND FOOT-END LOCKS AND WARNS THAT USER TRAINING IS REQURED. THE LOCKS ARE LABELED WITH WARNINGS THAT THEY NEED TO BE LOCKED PRIOR TO PATIENT TRANSFER. AN IN-SERVICE TRAINING WAS PERFORMED BY MIZUHO OSI PERSONNEL FOR HOSPITAL STAFF ON PROPER USE OF THE TABLE AND ENSURING THAT BOTH HEAD AND FOOT ENDS ARE LOCKED.

    Description of Event or Problem · 0

    PATIENT TRANSFERRED TO OPERATION TABLE. THE HEAD END ROTATION KNOB WAS LOCKED, AND THE FOOT END COLUMN WAS NOT LOCKED. STAFF NOTICED SOME INSTABILITY IN THE TABLE AND SWUNG OUT FROM THE PATIENT. THE PATIENT FELL TO THE FLOOR. THE PATIENT WAS EXAMINED; RECEIVED CT SCANS AND TRAUMA WORK-UP WITH NO IDENTIFIED PHYSICAL CONCERNS FROM THE INCIDENT.

    Description of Event or Problem · 0

    PATIENT TRANSFERRED TO OPERATION TABLE. THE HEAD END ROTATION KNOB WAS LOCKED, AND THE FOOT END COLUMN WAS NOT LOCKED. STAFF NOTICED SOME INSTABILITY IN THE TABLE, ATTEMPTED TROUBLESHOOTING BY UNLOCKING THE OTHER END. TABLETOP SWUNG OUT AND PATIENT FELL TO THE FLOOR. THE PATIENT WAS EXAMINED; RECEIVED CT SCANS AND TRAUMA WORK-UP WITH NO IDENTIFIED PHYSICAL CONCERNS FROM THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061852 ADVANCED CONTROL I-BASE, DC OPERATING TABLE JEA MIZUHO OSI 5803 00842430106026

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Unknown Other