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Model Number G136 |
Device Problems
Restricted Flow rate (1248); Overheating of Device (1437); Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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There has been a previous report received where lack of water flow has caused an overheating insert.Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr 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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Event Description
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While the customer was using a g136 scaler, they allege that the unit has no water and got hot.No injury was reported from the alleged event.
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Manufacturer Narrative
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Poor to no water flow due to a damaged hp cable, water flow control, dirty water filter, low batteries.
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Search Alerts/Recalls
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