Two's Company, Inc.

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

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·December 20, 2016

INTELISWAB COVID-19 RAPID TEST

FDA Adverse Event

Malfunction ·ORASURE TECHNOLOGIES, INC.·Product code QKP·January 12, 2023

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·April 23, 2020

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·October 4, 2019

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·January 17, 2025

BRAUN

FDA Adverse Event

Malfunction ·KAZ, INC.·Product code FLL·December 7, 2015

VICKS

FDA Adverse Event

Injury ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code KFZ·December 2, 2016

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·November 21, 2017

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·July 21, 2017

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code FLL·January 2, 2025

SMARTTEMP

FDA Adverse Event

Injury ·KAZ USA, INC.·Product code IME·November 25, 2015

EVITA

FDA Adverse Event

Malfunction ·DRAGER MEDICAL AG & CO. KGAA·Product code CBK·March 3, 2003

SMART TEMP

FDA Adverse Event

Injury ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code IME·August 29, 2019

DECANAV ELECTROPHYSIOLOGY CATHETER

FDA Adverse Event

Malfunction ·BIOSENSE WEBSTER INC·Product code DRF·December 4, 2023

TMJ IMPLANTS

FDA Adverse Event

Injury ·TMJ IMPLANTS INC.·Product code LZD·July 27, 2004

BRAUN

FDA Adverse Event

Malfunction ·KAZ USA, INC.·Product code FLL·February 2, 2016

CVS HEALTH

FDA Adverse Event

Injury ·KAZ USA, INC., A HELEN OF TROY COMPANY·Product code KFZ·May 1, 2019

1ST RESPONSE MANUAL RESUSCITATOR, ADULT

FDA Adverse Event

Injury ·SIMS PORTEX, INC.·Product code BTM·March 20, 1998

4.0MM RIGID SCREW, SELF DRILLING, 16MM

FDA Adverse Event

Injury ·GLOBUS MEDICAL, INC.·Product code KWQ·May 7, 2009