BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANA ORTHOPEDIC SURGERY TABLE

    MDR report key: 12916892 · Received December 1, 2021

    Report

    Report Number
    MW5105726
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 29, 2021
    Report Date
    November 30, 2021
    Manufacturer
    MIZUHO AMERICA INC. / MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HANA ORTHOPEDIC SURGERY TABLE WOULD NOT FUNCTION EVEN AFTER THOROUGH TROUBLESHOOTING. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811972 HANA ORTHOPEDIC SURGERY TABLE TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED JEA MIZUHO AMERICA INC. / MIZUHO ORTHOPEDIC SYSTEMS, INC. 6875

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male