During the procedure, signal and communication issues occurred and the case was cancelled.There were no ecg signals and no communication from the amplifier to the claris system.All connections were checked and all systems were power cycled.Tests were run on the amplifier which confirmed it would not communicate.Upon starting the amplifier, the usual 3 beeps were not heard.The amplifier was power cycled and tested twice which did not resolve the issue.The case was cancelled with no consequences to the patient.The procedure has been rescheduled.
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One workmate claris amplifier was received for evaluation.Visual inspection revealed the connectors, switches, and labels had no physical damage.All of the mounting hardware was secured.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined that no non-conformances were identified that are related to the reported event.As received, the returned workmate claris amplifier was powered on and successful communication was established with the test standard workmate claris computer using the test media converter.A basic signal acquisition/quality test which included the surface ecg, baseline, amplitude and stimulus switching were performed and confirmed that the returned amplifier performed within the factory specifications.The communication test was run for several hours and no loss or drop in communication was observed.The cause for the reported communication issue and subsequent procedure cancellation remain unknown.
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