BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WARM WEIGHT INFANT SCALE N10

    MDR report key: 381966 · Received March 10, 2002

    Report

    Report Number
    MW1024359
    Event Type
    Injury
    Date Received
    March 10, 2002
    Date of Event
    May 12, 2001
    Report Date
    March 10, 2002
    Manufacturer
    *
    Product Code
    FRW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WEIGHT SCALE HILL-ROM AIR-SHIELDS MODEL # N10 HAS SIDE-WALLS BUT NO END-WALLS. DURING WEIGH PROCEDURE, PT PUSHED WITH FEET AND SCOOTED HEAD-FIRST BACKWARDS OFF THE END OF THE TRAY. PT LANDED ON CONCRETE-BASED FLOOR FROM HEIGHT OF 3-4 FT. PT SUSTAINED HEAD INJURY. SPOKESMAN FOR MFR OF DEVICE STATED "..IT CAN BE ASSUMED THAT PT WAS LEFT UNATTENDED". MFR'S ASSUMPTION IS WRONG. PT WAS NEVER LEFT UNATTENDED. NURSE SIMPLY GLANCED DOWNWARD TO THE WEIGHT READ-OUT PANEL, LOCATED BENEATH THE SCALE, IN ORDER TO READ THE WEIGHT. AT THIS VERY MOMENT, PT SELF-CATAPULTED OFF THE END OF THE SCALE. WHEN A DRIVER GLANCES AT THE SPEEDOMETER ON THE DASH WHILE DRIVING, IT DOES NOT MEAN THAT THE MOVING VEHICLE HAS BEEN LEFT UNATTENDED. MFR'S RESPONSE WAS DEFENSIVE AND NOT HELPFUL IN PREVENTING THIS TYPE OF ACCIDENT FROM RECURRING. DEVICE SHOULD BE RECALLED. WARNINGS SHOULD BE SENT TO CURRENT OWNERS OF THIS SCALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WARM WEIGHT INFANT SCALE N10 INFANT WEIGHT SCALE FRW * N10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Hospitalization| L