Catalog Number 66802134 |
Device Problems
Overheating of Device (1437); Charging Problem (2892)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference (b)(4).
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Event Description
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It was reported that, the renasys touch non connect 4th ed device had problems maintaining the charge and overheats.As this happened in a non-surgical environment, there was not patient involvement.
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Manufacturer Narrative
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D4: lot#: not applicable, unique identifier (udi)# (b)(4).
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Manufacturer Narrative
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B5: updated description.H3: updated device evaluation status.H6: updated codes.H10 additional information: the device was returned for evaluation with no faults found.The event cannot be confirmed.Visual inspection reported the back case required replacing.Functional evaluation confirmed no faults with charging were found.The battery level was 87% upon arrival and the device was placed under charge for 1.5 hours.No signs of overheating or heat damage was observed.The instruction for use details that ambient temperature may affect charging.The ifu explains to allow the temperature to be reduced and once the temperature is reduced, charging will recommence.A documentation review has been conducted, confirming previous complaints of this nature.No historical escalations or manufacturing problems were observed.A review of the device history confirmed that no manufacturing problems where observed.The instructions for use and risk files, mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.
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Event Description
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It was reported that the renasys touch non connect 4th ed device had problems maintaining the charge and overheats.As the issue was observed outside of treatment, there was no patient involvement.
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Search Alerts/Recalls
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