BEUDAMED
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    Innovative Product Brands Inc.

    Manufacturer
    🇺🇸 United States

    PUMP MMT-722

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 10, 2019

    PUMP MMT-554

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 30, 2019

    620G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 30, 2019

    ID NOW COVID-19

    FDA Adverse Event
    Injury ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QJR·July 14, 2021

    VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JQP·March 6, 2006

    Brand Name: QuietCare, Model Numbers QC200403, v.02; QC200403, v.03; QC200403, v.04 -- Classification Name: System, Environmental Control, Powered. -- Firm on label: Manufacturer Living Independently Group, Inc., A wholly owned subsidiary of General Electric Company, PO Box 1466, New York, NY 10116 USA, 1-866-772-8243 --- The system is a passive behavior-monitoring device. QuietCare uses strategically placed, unobtrusive, passive wireless infrared pyroelectric sensors in the senior's residence to detect their movement. Data from these sensors are sent to a base station that periodically transmits the information to a centralized secure file server through standard phone lines over a toll-free number. Sophisticated algorithms analyze the data, learning each individual's normal patterns of behavior. When the system detects significant deviations from these baselines it automatically alerts designated caregivers. QuietCare also generates alerts of late wake-ups, potential bathroom falls and if household temperatures become dangerously low or high. The behavioral changes that the system tracks can often serve as subtle indicators of the potential emerging health problems. These changes include: nighttime bathroom usage, entering or exiting the bedroom at a different time than usual, change in the number of times the refrigerator door is opened/closed change in the number of times the medicine cabinet door is opened/closed. The intended users of the QuietCare device are the caregivers at the Assisted Living Facilities and Independent Living Facilities. The monitored individuals (seniors) do not actively operate the device and the device function is not dependent upon the senior resident's ability to use the device. --- Class 2 device, 510(k) exempt, Device Listing Number D117156.

    FDA Recall
    Terminated ·Intel-GE Care Innovations LLC·Product code IQA·August 1, 2011

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    RIOMAVIX LTD

    Authorized representative
    🇪🇸 Spain·400 Manufacturers·4531 Devices

    MediMark Europe Sarl.

    Authorized representative
    🇫🇷 France·35 Manufacturers·3394 Devices

    Lotus NL B.V.

    Authorized representative
    🇳🇱 Netherlands·584 Manufacturers·21427 Devices