BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIZUHO OSI HANA TABLE

    MDR report key: 8703844 · Received June 14, 2019

    Report

    Report Number
    MW5087397
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    June 4, 2019
    Report Date
    June 12, 2019
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT SURGERY COMPLETE, PREPARING TO TRANSFER PT FROM OPERATING ROOM TABLE (HANA TABLE) TO IN-PATIENT BED. REMOVED PERINEAL POST, HAD PT CROSS ARMS ACROSS CHEST, WHEN PT CROSSED LEFT ARM ACROSS CHEST, PT ROLLED TO THE RIGHT FALLING OFF OPERATING ROOM TABLE. PT FELL SLOWLY OFF OPERATING ROOM TABLE, LEFT FOOT COMING OUT OF HANA TABLE BOOT WHILE RIGHT FOOT STAYED IN BOOT ATTACHED TO TABLE. PT SUSTAINED A FRACTURED ANKLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495565 MIZUHO OSI HANA TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO OSI 6875

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization