BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECA

    MDR report key: 7319859 · Received March 7, 2018

    Report

    Report Number
    7319859
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    March 5, 2018
    Report Date
    March 6, 2018
    Manufacturer
    SECA CORP
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BOTH WHEELS ON THE END OF THE CART FELL OFF WHEN THE CART WAS MOVED SLIGHTLY DURING THE WEIGHING PROCESS, THE PARENTS CAUGHT THE INFANT AS IT WAS SLIDING OFF THE SCALE WHICH WAS TILTED. MANUFACTURER RESPONSE FOR WHEELED CART, CUSTOM MADE FOR THE SCALE, SECA (PER SITE REPORTER) MANUFACTURER WAS CONCERNED AND REQUESTED TO BE KEPT IN THE LOOP ON THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162966 SECA WHEELED CART FRW SECA CORP 402 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR THE DEVICE THAT FAILED WAS A CART THAT A INFANT SC