BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECA 403 BABY SCALE CART

    MDR report key: 10754719 · Received October 29, 2020

    Report

    Report Number
    10754719
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 21, 2020
    Manufacturer
    SECA
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A SECA BABY CART MODEL 403 WAS DROPPED OFF IN THE CLINICAL ENGINEERING DEPARTMENT WITH ONE OF ITS REAR WHEELS DETACHED. AFTER INSPECTION, IT APPEARS THE REAR WHEEL'S SLOTTED SOCKET THAT HELD THE WHEEL'S BOLT HAD EXPANDED AND WORN. THIS BABY CART'S FRONT WHEELS HAD ALREADY BEEN REMEDIATED FOR A CLASS 2 DEVICE RECALL WHERE THE FRONT BRAKE WHEELS COULD LOOSEN AND DETACH. RECALL NUMBER Z-1429-2020. MANUFACTURER RESPONSE FOR BABY SCALE CART, SECA (PER SITE REPORTER) THEY ACKNOWLEDGE AND THANK US FOR SHARING. NO FURTHER COMMUNICATIONS ABOUT THIS ISSUE WITH THE BABY CART RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221381 SECA 403 BABY SCALE CART SCALE, PATIENT FRW SECA 403

    Patients

    Seq Age Sex Outcome Treatment
    1