BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOUND F37

    MDR report key: 8496094 · Received April 9, 2019

    Report

    Report Number
    8030405-2019-00002
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 9, 2019
    Manufacturer
    HITACHI MEDICAL CORPORATION
    Product Code
    IYN
    PMA / PMN Number
    K122341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROSOUND F37 IS A DIAGNOSTIC ULTRASOUND SYSTEM. HITACHI RECEIVED A COMPLAINT ON (B)(6) 2019 REGARDING THE F37 ULTRASOUND SYSTEM. THE SITE REPORTED A DISCREPANCY BETWEEN THE EFW (ESTIMATED FETAL WEIGHT) AND PERCENTILE NUMBER TO THE NUMBER THAT IS GRAPHED IN THE OB REPORT. HITACHI APPLICATIONS CONTACTED THE CUSTOMER AND REVIEWED THEIR PRESET SETTINGS. PRESET SETTINGS INCLUDE SEVERAL DIFFERENT CALCULATIONS (I.E. HADLOCK, DOUBILET), WHICH THE CUSTOMERS CAN SELECT. THE SETTINGS DICTATE THE CALCULATION TABLE THAT THE SYSTEM WILL USE TO PERFORM THE CALCULATION AND ALSO AFFECT THE LABELS FOR THE GRAPH AND WEIGHT ESTIMATES OF THE OB REPORTS. THE SETTINGS CAN BE MODIFIED BY THE CUSTOMER AT WILL. HITACHI APPLICATIONS ASSISTED THE CUSTOMER IN CHANGING THEIR PRESET SETTINGS TO HADLOCK5 FOR THE APPROPRIATE CALCULATION AND GROWTH TABLE. THE SYSTEM IS OPERATING WITHIN SPECIFICATIONS AFTER APPLYING THE CHANGE. THE ROOT CAUSE OF THE PROBLEM IS USER ERROR. NOTE: THE PROSOUND F37 WAS MANUFACTURED IN (B)(4) BUT MANUFACTURING HAS BEEN MOVED TO ANOTHER SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2019, HITACHI RECEIVED A COMPLAINT REGARDING THE F37 ULTRASOUND SYSTEM. THE SITE REPORTED A DISCREPANCY BETWEEN THE EFW (ESTIMATED FETAL WEIGHT) AND PERCENTILE NUMBER TO THE NUMBER THAT IS GRAPHED IN THE OB REPORT. THE SITE DID NOT REPORT ANY OTHER ISSUE WITH THE ULTRASOUND SYSTEM OR OB REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287514 PROSOUND F37 PROSOUND F37 IYN HITACHI MEDICAL CORPORATION PROSOUND F37 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other