BEUDAMED
    FDA Enforcement Class II Terminated

    CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.

    Recall: Z-2554-2014 · Reported September 3, 2014

    Enforcement

    Recall Number
    Z-2554-2014
    Event ID
    68961
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Curbell Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 3, 2014
    Initiation Date
    August 5, 2014
    Classification Date
    August 26, 2014
    Termination Date
    February 28, 2017
    Address
    20 Centre Dr, N/A, Orchard Park, NY, 14127-4102, United States

    Description

    CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed, chair, floor mat, or toilet seat. The monitor will sound an alarm.

    Reason

    The firm became aware of a potential problem that was initiated by a customer complaint. After consultation with the manufacturer, it was discovered that a resistor was incorrectly placed within the circuit board on the monitor. This change to the resistor was a planned change to address a product improvement (improve battery drain). However, this modification rendered the monitor's alarm via the nurse call communication port to not function.

    Code Info

    Lot 0414

    Distribution

    Nationwide, Canada, Ireland, Italy

    Quantity

    Domestic: 112 units; Foreign: 211 units