BEUDAMED
    FDA Adverse Event Summary report: N

    ADVANCED CONTROL PAD SYSTEM

    MDR report key: 1033064 · Received April 21, 2008

    Report

    Report Number
    2921578-2008-00010
    Date Received
    April 21, 2008
    Date of Event
    January 30, 2008
    Report Date
    April 15, 2008
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FWY
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACTED RISK MANAGEMENT FOR THE HOSPITAL, SHE WAS HAPPY WE CALLED CONCERNING HER ISSUES. SHE IMMEDIATELY STATED THAT THE TABLE IS CURRENTLY IN USE AND THEY ARE NO LONGER HAVING ISSUES WITH THE PRODUCT. I ASKED IF THEY WERE USING PATIENT KIT COVERS OVER THE PAD AND SHE WAS NOT SURE. I ASKED IF THE ANESTHESIOLOGIST WAS MONITORING THE PRESSURE POINTS ON THE PATIENT. SHE STATED THAT THEY WERE NO LONGER CHECKING THE PT BECAUSE THEY BELIEVED THE MASSAGING ACTION ELIMINATED FURTHER NEED FOR PT MONITORING. I INFORMED HER THAT THE PADS PROVIDE MASSAGING ACTIONS. HOWEVER, THAT SHOULD NOT ELIMINATE THE NEED TO CHECK FOR PRESSURE PROBLEMS WITH ANY PATIENT. SHE ALSO REQUESTED THAT THE SALES REP COME INTO THE HOSPITAL TO COMPLETE AN IN-SERVICE TRAINING ON THE TABLE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT WO PATIENTS SUFFERED SKIN ABRASIONS AFTER USE ON ADVANCED CONTROL PAD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED CONTROL PAD SYSTEM OPERATING ROOM TABLE FWY MIZUHO ORTHOPEDIC SYSTEMS, INC. 5943AP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 5803 ADVANCED CONTROL BASE