Alerta De Seguridad para Product: Carescape Monitor. Model: B850. Anvisa Registry n ° 80071260167.

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

If the PDM is quickly disconnected and reconnected (a cycle of less than 10 seconds) from a Carescape Bx50 monitor after a "Patient Discharge" or during active monitoring, the ECG waveform and its associated parameters can be analyzed incorrectly. ECG heart rate parameter data, ECG waveform analysis, and other ECG parameter measurements are displayed with values ​​that will be lower than the actual physiological condition of the patient. The problem potentially affects heart rate, ST segment ECG analysis, ECG analysis of 12 electrodes; ECG, SPO2, respiration and invasive blood pressure waveforms, both locally and in the CIC (Centro de Informação Clinicas Registro ANVISA nº 80071260228); and the data displayed in the CIC can indicate an output and data. Bed and CIC data can not accurately represent the parameters being measured. Severe or acute patients rely on physiological monitoring to adjust care and prevent adverse outcomes. In doing so, health professionals rely on the accuracy and timeliness of the monitor's results, with both visual and audible alarm signals for the best patient care. The most serious risk situations occur when both the visual and sound signals are incorrect or at the wrong time. In this incident, there are several parameters that change the display and sound warnings in a clinically significant way, which can lead to inadequate treatments, or delay appropriate treatments. The temporal synchronization of the waves causes a false sense that the waveforms are correct. The normal but slow heartbeat frequency in the 50-100 range would be shown to be 25-50 beats / min, would lead to inadequate treatment, or could lead to inappropriate withdrawal of other suitable bradycardia-inducing medications. Incorrect assessment of ST segment waveforms and ST deviations may lead to delayed treatment of ischemia; the delay in ischemia therapy may lead to complete myocardial infarction. Any of these individual or collective scenarios can result in care that causes permanent damage. CIC display errors are less likely to cause permanent (and not more likely) damage because there are obvious artifacts that suggest a malfunction of the system. This would lead to investigations into system performance, system restart or at least the discovery of the defect.