BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETECTO SCALE

    MDR report key: 1901739 · Received November 9, 2010

    Report

    Report Number
    1901739
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 9, 2010
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BABY SCALE READINGS INACCURATE BY 5-10% WT DIFFERENCES. BIOMED HAS CALIBRATED AND ATTEMPTED TO REMEDY THE ISSUE, AND WHEN THE SCALE READS THEIR TEST USING A 10 POUND WEIGHT IT READS ACCURATELY, BUT WHEN WEIGHING A MOVING INFANT THE WEIGHTS ARE CONSISTENTLY OFF BY 5-10% OF THE ACTUAL WEIGHT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SCALE DOES NOT READ ACCURATELY AND CONSISTENTLY ESPECIALLY WITH INFANT MOVING INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DETECTO SCALE SCALE, INFANT FRW CARDINAL HEALTH 6745 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES