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Catalog Number 72200616S |
Device Problems
Overheating of Device (1437); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No evaluation conducted to date, awaiting receipt of device.
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Event Description
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It was reported that before the procedure the mdu did not work at first, when it started to work it became hot.A backup was used to perform the procedure.No delay or complications were noted as a result.
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Manufacturer Narrative
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The reported complaint of overheating could not be confirmed.Unit was tested at speed settings between 100 and 10,000 rpm¿s in forward and reverse for 5 minutes each.Also oscillate for 5 minutes in highest setting (9).Product was tested on a known good dyonics power, dii, and dii eip control units with and without footswitch.At no time did mdu overheat.All functions perform as expected.No problem found.A review of the device history record was performed which confirmed no inconsistencies.
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Search Alerts/Recalls
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