BEUDAMED
    FDA Adverse Event Summary report: N

    JACKSON SPINAL TABLE SYSTEM

    MDR report key: 1961619 · Received December 16, 2010

    Report

    Report Number
    2921578-2010-00017
    Date Received
    December 16, 2010
    Report Date
    December 14, 2010
    Manufacturer
    MIZUHO OSI
    Product Code
    JEB
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR INITIAL INVESTIGATION HAS FOUND THE CUSTOMER TO NOT USING THE COVERS ON THE PADS FOR SURGERY AND SENT SOME PATIENT KITS FOR THE HOSPITAL TO TRIAL ((B)(6) 2010). AT THAT TIME OF CONTACT, WE ALSO REVIEWED THE TABLE AND REQUESTED A PREVENTATIVE MAINTENANCE AS THE TABLE'S ARMBOARDS WERE STUCK IN POSITION WITH UNK DEBRIS. SINCE THE INCIDENT OUR SALES REP HAS TRIED TO CONTACT THE HOSPITAL BUT HAS NOT RECEIVED A RESPONSE.

    Description of Event or Problem · 1

    THE NURSE MANAGER AT (B)(6) HOSPITAL HAS CONTACTED MIZUHO OSI CONCERNING PATIENTS HAVING SKIN TEARS. THE PATIENTS WERE OBESE WITH LARGE ABDOMENS AND DIFFICULT TO POSITION. AFTER THE SURGERY, THE PATIENTS WERE TURNED AND SHOWED SIGNS OF SKIN TEARS (GOING AND CHEST REGIONS). THEY WANTED TO KNOW IF THERE WERE OPTIONS TO CONTROL THIS ISSUE (IN-SERVICE, ADD'L PADS, ETC.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JACKSON SPINAL TABLE SYSTEM OPERATING ROOM TABLE JEB MIZUHO OSI

    Patients

    Seq Age Sex Outcome Treatment
    1