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Model Number 7211010 |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/05/2023 |
Event Type
malfunction
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Event Description
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It was reported that during unspecified procedure, the dyonics 25 control unit was warm.The procedure was finished with a smith and nephew back up device.No delay or further complications were reported.
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Manufacturer Narrative
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H10: internal complaint reference : (b)(4).
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Manufacturer Narrative
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Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.The reported malfunction was not duplicated during functional testing.No overheating was noted.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause was not determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the reported event include a failure of a concomitant device.No containment or corrective actions are recommended at this time.
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Search Alerts/Recalls
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