BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLE, HANA, 110 V

    MDR report key: 18477829 · Received January 9, 2024

    Report

    Report Number
    2921578-2024-00001
    Event Type
    Injury
    Date Received
    January 9, 2024
    Date of Event
    December 19, 2023
    Report Date
    February 1, 2024
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    UDI-DI
    00842430108747
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION OBTAINED FROM DEVICE EVALUATION AND INVESTIGATION, THERE NO PROBLEMS WITH THE DEVICE ITSELF. SAFETY STRAPS WERE NOT USED ON THE PATIENT DURING THE HIP FRACTURE SURGERY DUE TO THE ANATOMICAL CONDITIONS OF THE PATIENT. THE OWNER'S MANUAL OF THE DEVICE HAS SEVERAL WARNINGS THAT INDICATE USING SAFETY STRAPS WHEN THE DEVICE IS IN USE. MIZUHO OSI DOES NOT RECOMMEND TO STOP USING SAFETY STRAPS UNDER ANY CONDITIONS. THUS THIS INCIDENT IS DEEMED AS INTENTIONAL OFF-LABEL USE OF THE DEVICE ALONG WITH USER ERROR FOR FAILURE TO FOLLOW MANUFACTURER'S RECOMMENDED GUIDELINES AND RECOGNIZED BEST PRACTICES FOR PATIENT SAFETY. AN EDUCATIONAL IN-TRAINING WAS PERFORMED AT THE HOSPITAL BY QUALIFIED MIZUHO OSI PERSONNEL FOLLOWING THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HIP FRACTURE SURGERY, A PATIENT FELL OFF THE TABLE AND THE SAFETY STRAP WAS NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HIP FRACTURE SURGERY, A PATIENT FELL OFF THE TABLE AND THE SAFETY STRAP WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461847 TABLE, HANA, 110 V OPERATING TABLE JEA MIZUHO OSI 6875 00842430108747

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other