Model Number G124 |
Device Problems
Restricted Flow rate (1248); Component Missing (2306); Sparking (2595)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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While the customer was using a g124 cavitron select sps, they allege that unit had no water flow and the unit sparked when it was plugged in to the power supply.No injury was reported from the alleged event.
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Manufacturer Narrative
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There has been a previous report received where this malfunction resulted in a serious injury.Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such.As such, this event is reportable per 21cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
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Manufacturer Narrative
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Could not duplicate issue "no water flow".Power supply input pins contacting each other, causing sparks when unit is on and someone plugs in power supply.Refrain from plugging in power supply while unit knob is in on position.Turn off unit before plugging in power supply.
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Search Alerts/Recalls
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