BEUDAMED
    FDA Recall Terminated

    Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 IOV.

    Recall: Z-0143-2015 · Initiated September 29, 2014

    Recall

    Recall Number
    Z-0143-2015
    Event Number
    69406
    Firm
    Merge Healthcare, Inc.
    FEI Number
    1000116130
    Product Code
    DQK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 29, 2014
    Posted
    October 28, 2014
    Terminated
    August 25, 2016
    Address
    900 Walnut Ridge Dr, Hartland, WI, 53029-8347

    Description

    Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial interface. All vital parameters and evaluations are registered and calculated in the Patient Data Module. This data is then transmitted to the HeartSuite Hemodynamics Hemo Monitor PC via the serial interface. All data can be shown and monitored on the HeartSuite Hemodynamics Hemo Monitor PC. The Patient Data Module uses an internal battery charged from an external power input (RS 232/12V). The power supply, like the data transmission, is completely isolated from the visualization unit. The HeartSuite Hemodynamics Hemo Monitor PC is powered via the normal mains connection 230V/1 IOV.

    Reason

    It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.

    Action

    Consignees were e mailed on 5/29/14 a Merge "Important Alert" letter. The letter described the problem and the product involved in the recall. Informed consignees that they had the opportunity to replace the Nellcor SpO2 module with a Masimo SpO2 module free of charge. The letter also provided Clinical Information and the Next Steps to follow. This included to contact Merge Technical Support if they wanted to replace their Nellcor module. For questions, they can contact Lee Harrop, Director Solutions Management, Cardiology, 386-239-2224, [email protected]. A second letter was sent Sept. 11, 2014 via e-mail. Consignees were made aware of a firmware patch available.

    Distribution

    Nationwide Distribution including the states of AZ, CA, FL, IL, IA, MA, MO, OH, SC, TN, and WI.

    Quantity

    52