One ensite velocity¿ system dws6 velocity v.4.0.1 was returned for analysis.Visual inspection revealed the input/output connectors appeared to be free of physical damage, all of the mounting hardware was secured and normal wear was observed on the exterior enclosure.The ensite velocity dws was powered on and passed a power on self-test prior to successfully loading to the main application login screen.Additional hardware evaluation confirmed that the returned ensite velocity dws performed as expected during the remaining of the system hardware diagnostics.During the software evaluation, the reported geometry shift was confirmed.The following are potential reasons why a catheter display shift can occur clinically: patient repositioning such as upper limb motion and displacement of the chest or abdomen.Positional reference electrode dislodgement.Non-transient shifts can be related to the gravitational shift of body weight as the patient relaxes during the procedure and subsequent gradual impedance changes in the body.Patch connection, adhesion, or placement issues.Powering up or shutting down other lab equipment can cause electro-magnetic interference with the abbott equipment.In addition, changing connections to other lab equipment such as a stim generator can cause catheter shift.Review of the ensite cardiac mapping system also verified that in some cases enabling respiration compensation can cause the computed catheter locations to show motion.The relatively slow adaptation of respiration compensation in some situations is expected behavior and is intentional, as adapting too fast can cause adaptation to artifacts unrelated to respiration and can cause failure to compensate respiration.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with abbott specifications and procedures.
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