—#164277

Product

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 product code: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K030407
Affected lot / code info: Reorder number 920654235: Serial numbers 4068892, 4068893, 4068894, and 4068895; Reorder number 920654235A: Serial number 4061288; Reorder number 920654335A: Serial numbers 4059004, 4059005, 4068891, and 4069354; Reorder Number 920674235A: 4064435

Why it was recalled

Some printing modes on the devices may not function properly (tabular data printing, real-time continuous printouts, and automatic interrupt print feature).

Root cause (FDA determination)

Software design

Action the firm took

Smiths Medical sent an Urgent Medical Device Letters dated 11/29/2017 via FedEx tracked mailing. The letter identified the affected product, problem and actions to be taken. For questions call Smith Medical Customer Service at 1-800-258-5361.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide in the states of CO and MT. Foreign distribution was to Armenia.

Timeline

Recall initiated: 2017-11-29
Terminated: 2018-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #164277. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.