9 results
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201ms
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Sources: EU EUDAMED, US FDA
Accessories for Measuring and Monitoring Device for Vital Signs
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·17 devices
Accessories for Measuring and Monitoring Device for Vital Signs
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·147 devices
Reusable Accessories Measuring and Monitoring Device for Vital Signs
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Fukuda Denshi Co., Ltd.·1 device
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·July 18, 2018
VSM6800/SPN/ST/RADIO/PLUG66
FDA Adverse Event
Malfunction
·WELCH ALLYN INC.·Product code MWI·April 22, 2022
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the reorder numbers have to do with certain functions being installed or not installed.) Product Usage: The 9200 vital signs monitor is intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of the hospital or clinic where low end monitoring systems are needed. The basic monitor package includes ECG (3 lead/5 lead), impedance respiration (RSP), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), two invasive blood pressures (P1 and P2), and two temperature channels (T1 and T2). Capnography (ETCO2, inCO2, RR), a two-inch internal, graphical/alphanumeric printer and a battery are provided as options. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The device will provide fast, reliable measurements on patients ranging from neonate to adults when using the appropriate BCI accessories. The impedance respiration and capnography parameters are available in adult and pediatric mode only and are not intended for neonatal monitoring. The monitor may be connected to the Life Sensing Instrument Company, Inc. HTS 820 Central Station for remote monitoring of patient status. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code CCK·November 29, 2017
CARESCAPE B650
FDA Adverse Event
Injury
·GE HEALTHCARE FINLAND OY·Product code MHX·October 24, 2015
OPTUM TELEHEALTH
FDA Adverse Event
Malfunction
·OPTUMHEALTH CARE SOLUTIONS, INC.·Product code DRG·March 23, 2017
VASONOVA VPS G4 CONSOLE/ACCESSORIES
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code OBJ·February 13, 2024