BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5855 ORTHOPEDIC TABLE TOP

    MDR report key: 2243746 · Received July 29, 2011

    Report

    Report Number
    2921578-2011-00021
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A REPAIR OF A 5855 ORTHOPEDIC TABLE TOP, THE TECHNICIAN FOUND THE TABLE SPAR CONNECTING THE TABLE TOP HAD BECOME CRACKED AND SEPARATING FROM THE SPAR MOUNT ASSEMBLY. WILL ADVISE UPON COMPLETION OF INVESTIGATION ((B)(4) 2011).

    Description of Event or Problem · 1

    DURING A REPAIR OF A 5855 ORTHOPEDIC TABLE TOP, THE TECHNICIAN FOUND THE TABLE SPAR CONNECTING THE TABLE TOP HAD BECOME CRACKED AND SEPARATED FROM THE SPAR MOUNT ASSEMBLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5855 ORTHOPEDIC TABLE TOP ORTHOPEDIC OPERATING ROOM TABLE JEA MIZUHO OSI 5855

    Patients

    Seq Age Sex Outcome Treatment
    1