BEUDAMED
    FDA Recall Terminated

    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.

    Recall: Z-0263-2012 · Initiated October 18, 2011

    Recall

    Recall Number
    Z-0263-2012
    Event Number
    60155
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 18, 2011
    Posted
    November 22, 2011
    Terminated
    April 1, 2013
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.

    Reason

    During product training on the Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. In addition, a misalignment of ECG and ART waveforms delivered from an Infinity(RO Acute Care System (IACS) Monitoring Solution (M540) was observed on the Infinity Central Station.

    Action

    The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, "Check the patient and treat if necessary". If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed on the Cockpit screen (or any other change to the auto display screen layout).

    Distribution

    Nationwide distribution - IL

    Quantity

    476