BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    331I SECA SCALE

    MDR report key: 24145229 · Received January 22, 2026

    Report

    Report Number
    24145229
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    October 1, 2024
    Report Date
    December 30, 2025
    Manufacturer
    SECA
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    WE HAVE HAD OVER 80 REQUESTS TO RECALIBRATE THE MEASURING ROD AND OVER 180 UNPLANNED REQUESTS FOR SERVICE ON THE INFANT SCALES ON TOP OF ANNUAL EVALUATIONS OF EACH SCALE. WE HAVE HAD THIS REQUEST FOR 90 COLUMN SCALES. ADDITIONALLY, A SCALE COME DOWN THAT IS OFF BY 118 GRAMS. WE TESTED 11 ADDITIONAL INFANT SCALES OF THOSE, ONE WAS FOUND OUT OF TOLERANCE (BY 8 GRAMS), AND 6 HAD A MEASURING ROD OUT OF CALIBRATION. EACH OF THE RODS WERE OFF BY 8.8 CM. THIS CALIBRATION ISSUE IS STILL OCCURRING DESPITE MAKING SURE TO POWER CYCLE AFTER RE-CALIBRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204191 331I SECA SCALE SCALE, PATIENT FRW SECA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Male