Model Number SYNERGYRF¿ CONSOLE |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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Event Description
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On (b)(6) 2023, it was reported by a sales representative via sems-06050578 that an ar-9800 synergyrf console had a lcd panel failure alarm turn on when the apollo was making an unusual noise during use when connected to the console.It was stated that the green power light for indicating the console has power was present during the event.This was discovered during an unspecified procedure with no patient harm.
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Search Alerts/Recalls
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