Model Number 7209807 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/09/2016 |
Event Type
malfunction
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Event Description
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It was reported the powermax elite mdu gets very hot when turned on.No patient injury or complications were reported.
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Manufacturer Narrative
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(b)(4).Note: this is not a follow up (g.7), this is the initial, 30 day report, however follow up was chosen as the system incorrectly believes there is a duplicate report and as such is rejecting the initial submission.
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Event Description
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According to the reporter: connector is broken.Occurred during testing.There was no patient involvement, patient injury, medical intervention, patient death, or labeling / packaging issues.The product will be returned.
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Manufacturer Narrative
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The reported complaint of overheating could not be confirmed.Product did not overheat during functional testing.No problem found.
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Manufacturer Narrative
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(b)(4).Post market vigilance (pmv) led an evaluation of one device.Damage was noted consistent with removing the cable connector from the control unit with excessive force, likely at a slight angle.Product analysis suggests the product was used in a surgical procedure.The reported condition was confirmed.Using excessive force to remove the cable connector from the control unit or removing the cable connector at an angle can damage the internal wiring of the power cord.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.No enhancements or improvements were generated for the reported condition.Should new information become available, the file will be re-opened and reassessed at that time.Note: due to submission failure as a result of duplication in the fda system, this report is being submitted as a follow-up #3 report.
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Search Alerts/Recalls
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