ST. JUDE MEDICAL, INC. WORKMATE CLARIS DISPLAY PLUS AMPLIFIER; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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Model Number H700150 |
Device Problems
Failure to Analyze Signal (1539); Unexpected Shutdown (4019)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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During the procedure, there was no signal, the computer froze and the procedure was cancelled.
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Manufacturer Narrative
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One workmate claris amplifier was received for evaluation.The amplifier was powered on but no communication was established with the test workmate claris computer.The single board computer (sbc) was temporarily replaced with a known good sbc board and successful communication was established.Using the test sbc board, 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.However, communication and signal were restored when the suspected sbc was reinstalled.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.The reported event was due to an intermittent sbc board.
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Search Alerts/Recalls
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