BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECA 333

    MDR report key: 21967312 · Received May 6, 2025

    Report

    Report Number
    21967312
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 4, 2025
    Report Date
    April 15, 2025
    Manufacturer
    SECA
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NO PATIENT OR STAFF HARM IDENTIFIED. THE HOSPITAL PURCHASED SCALES MADE BY SECA, STARTING IN [REDACTED]. TWO ISSUES HAVE BEEN IDENTIFIED. ISSUE #1: AS [REDACTED], 17 SCALES HAVE BEEN IDENTIFIED AS CRACKED. WE ARE CURRENTLY REVIEWING THE REMAINING INVENTORY. WE UTILIZED MEDLINE FOR A WHITE GLOVE INSTALLATION/ASSEMBLY OF THESE SCALES. ONE CONTRIBUTING FACTOR MAY BE THAT THE SCREW IN THE BACK WAS TIGHTENED TOO TIGHTLY. LOCATION OF THE HANDLE (LOW AND ONLY ON ONE SIDE) AND STRESS FROM MEASURING ROD MAY BE CONTRIBUTING FACTORS. THESE CRACKED SCALES ALL REQUIRE REPLACEMENT. ISSUE #2: IN EARLY [REDACTED], STAFF BEGAN NOTICING INACCURATE CALIBRATION RELATED TO THE STADIOMETER (HEIGHT) MEASURING RODS RESULTING IN INACCURATE HEIGHT MEASUREMENTS. AS OF [REDACTED], 10 OUT OF 140 SCALES WERE IDENTIFIED AS INACCURATELY CALIBRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103498 SECA 333 SCALE, PATIENT FRW SECA 333

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown