BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIZUHO/MST-7200-B

    MDR report key: 1490750 · Received September 28, 2009

    Report

    Report Number
    MW5012902
    Event Type
    Malfunction
    Date Received
    September 28, 2009
    Date of Event
    September 22, 2009
    Report Date
    September 28, 2009
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HEAT PUMP ON A SURGICAL TABLE WAS RUNNING CONTINUOUSLY AND OVERHEATED CAUSING THE LINE TO RUPTURE AND LEAK HYDRAULIC FLUID. THE PT AND STAFF WERE NOT INJURED. FOUND TO BE AN ELECTRONIC MALFUNCTION. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: CHIARI MALFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIZUHO/MST-7200-B TABLE, SURGICAL FQO MIZUHO AMERICA, INC. MIZUHO/MST-7200-B

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR