BEUDAMED
    FDA Recall 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 · Initiated August 5, 2014

    Recall

    Recall Number
    Z-2554-2014
    Event Number
    68961
    Firm
    Curbell Medical, Inc.
    FEI Number
    3000210521
    Product Code
    KMI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 5, 2014
    Posted
    August 26, 2014
    Terminated
    February 28, 2017
    Address
    20 Centre Dr, Orchard Park, NY, 14127-4102

    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.

    Action

    Urgent Medical Device Recall Letters (dated 8/01/14) and Response Forms were sent to the consignees via e-mail (w/read receipt) on 8/05/14.

    Distribution

    Nationwide, Canada, Ireland, Italy

    Quantity

    Domestic: 112 units; Foreign: 211 units