BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOUND F37

    MDR report key: 6449984 · Received March 31, 2017

    Report

    Report Number
    9610865-2016-00002
    Event Type
    Injury
    Date Received
    March 31, 2017
    Date of Event
    March 16, 2016
    Report Date
    March 16, 2016
    Manufacturer
    HITACHI LTD, HEALTHCARE TOKYO WORKS
    Product Code
    IYO
    PMA / PMN Number
    K122341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE F37 HAS A PROGRAMMABLE OB REPORT AND THE DOCTOR WAS NOT AWARE OF THE DEFAULT PROGRAMMING OF THE ESTIMATED FETAL WEIGHT PERCENTILE PARAMETER. HITACHI CONFIRMED THAT THE DISCREPANCY BETWEEN THE SYSTEM AND THE WEBSITE WAS DUE TO THE FACT THAT THEY WERE NOT USING THE SAME CALCULATION TABLES. THE F37 WAS PROGRAMMED TO DISPLAY DOUBILET EFW VALUES, WHILE THE WEBSITE ESTIMATED THE EFW PERCENTILE USING HADLOCK CALCULATION TABLES. THE PHYSICIAN DID NOT REPORT ANY OTHER ISSUES WITH THE DISPLAYED OB REPORT, WHICH DISPLAYS MANY OTHER WEIGHT, HEIGHT, AND AGE ESTIMATES. DEVICE EVALUATED BY MFR: EVAL USE CONDITIONS CONFIRMED AT OFFICE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A FACILITY REPORTED AN ADVERSE EVENT INVOLVING THE HITACHI PROSOUND F37 ULTRASOUND SYSTEM. THE PHYSICIAN EMAILED THE COMPANY AND CLAIMED THAT "COMPARING THE MEASUREMENTS WITH THE PERCENTILES ON (B)(4), THE NUMBERS FROM THE F37 MACHINE ARE OFF." SHE ALSO STATED THAT "THEY HAD A PATIENT WITH A DEAD BABY LAST MONTH." THE PATIENT HAD AN ULTRASOUND A FEW DAYS BEFORE THE BABY WAS DEAD. THE U.S MACHINE REPORTED 24% FOR WEIGHT, BUT (B)(4) REPORTED 6% FOR THE SAME DATA. A 6% READING WOULD HAVE PROMPTED A REFERRAL AS SOON AS POSSIBLE. SHE NOTED BOTH MEASUREMENT TOOLS USE HADLOCK METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233349 PROSOUND F37 ULTRASONIC PULSED ECHO IMAGING SYSTEM IYO HITACHI LTD, HEALTHCARE TOKYO WORKS PROSOUND F37 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Congenital Anomaly