Alerta De Seguridad para Monitors of Electrocardiography. Electrocardiographic Monitoring Modules: (1) Model 90342, (2) Model 90344, (3) Model 90346, (4) Model 90348, (5) Model 90470, (6) Model 90478, (7) Model 90496

Safety alert

274

2002-01-25

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

An anomaly, which fails to detect low heart rates at a frequency of 12 to 15 beats per minute, may exist in the electrocardiographic monitoring module above. for this anomaly to occur, three things have to occur simultaneously: (1) the heart rate has to fall suddenly within a beat interval. (2) the rhythm of the heart has to fall within the oscillation of 12 to 15 beats per minute. (3) the heart's rhythm must remain within the oscillation of 12 to 15 beats per minute. in this condition, the software will not update, detect the change or may generate a low-beat alarm. there were no injuries or deaths in patients associated with this anomaly and any heart rate outside of this range will provide an appropriate alarm. the manufacturer initiated a field correction through a letter dated october 22, 2001, called the emergency medical device corrective action.

Make sure you have received Spacelabs' October 22, 2001 letter Identify and isolate any affected product in your inventory. Spacelabs is offering replacement software to correct the anomaly associated with the above modules. If you have the drives with models No. 90342, 90344, 90346, 90348, 90470, or 90478 in your inventory, the manufacturer is offering the opportunity to do an upgrade on its own. If you choose this action, you must sign up to be included in the program. The manufacturer will then provide, free of charge, the upgrade software for each affected unit and instructions on how to make the upgrades. After you complete and sign an installation modification report for each affected module and return the affected software for each module, you will receive $ 25 of credit in your account for each updated model, valid for maintenance or purchase of products within 12 months. For customers who choose not to participate in this opportunity or if you have the model no. 90496 upgrade software will be installed by the on-site representative of Spacelabs at no charge. The manufacturer estimates that each update will take about 30 minutes. Until your ECG modules are up-to-date the manufacturer recommends that you be aware of the above-mentioned anomaly to prevent any adverse events from happening. For more information, contact your local representative or directly with Spacelabs Technical Monitoring Support by phone 1 (206) 882-3700 in the USA.