BEUDAMED
    FDA Recall Open, Classified

    HAMILTON-C6, REF: 160021

    Recall: Z-1429-2023 · Initiated March 14, 2023

    Recall

    Recall Number
    Z-1429-2023
    Event Number
    91925
    Firm
    Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland
    FEI Number
    3001421318
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    March 14, 2023
    Posted
    April 25, 2023

    Description

    HAMILTON-C6, REF: 160021

    Reason

    Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.

    Action

    On 3/14/23, correction notices were emailed to health care facilities and distribution partners. Customers were told the following: 1) Firm will reach out to schedule the software update. 2) See Operation's Manual, Section 7.7, Safety Ventilation. The device must turn off to exit Safety Ventilation. 3) Complete and return the confirmation form to [email protected] 4) If the malfunction occurs take the following actions: a) Monitor your patient. b) Provide an alternative device for ventilation. c) Have the ventilator serviced. If you have questions or concerns, contact Technical Support at 1-800-426-6331, option #2, or email [email protected]

    Distribution

    US Nationwide distribution in the states of CA, MA, ID, NC, GA, FL, NV, PA, MO, KS, SC, NY, NM, WY, VA.

    Quantity

    103