BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT AND INFANT SCALE

    MDR report key: 33516 · Received June 19, 1996

    Report

    Report Number
    MW1009312
    Event Type
    Malfunction
    Date Received
    June 19, 1996
    Date of Event
    June 1, 1996
    Report Date
    June 18, 1996
    Manufacturer
    TANITA CORP OF AMERICA
    Product Code
    FRI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE MAIN PROBLEM IS UNDERSTANDING WHAT THE SCALE IS READING WHEN IT IS IN USE IN THE INFANT MODE. THE SCALE HAD TWO MODES, ONE FOR INFANTS, AND THE OTHER ONE FOR ADULTS. IT ALSO GIVES YOU TWO CHOICES, POUNDS AND KILOGRAMS. WHEN IT IS USED IN POUNDS, THE DISPLAY READS 0.00 POUNDS. WHEN IT IS IN POUNDS/OUNCES, IF FOR EXAMPLE IT READS 10.13, IT DOES NOT MEAN 10 POUNDS AND .13 DECIMALS, IT MEANS 10 POUNDS, AND .13 OUNCES. "WE WERE CONFUSED AND DECIDE TO SEND THE SCALE WAS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT AND INFANT SCALE SCALE FRI TANITA CORP OF AMERICA 1582 550824

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO