Model Number 66801496 |
Device Problems
Failure to Charge (1085); Overheating of Device (1437)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2022 |
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, during npwt, the renasys go gave failure in the charging connection section.It seemed burned.Treatment was resumed, with a greater 30 minutes delay, with a back-up device.Patient was not harmed, or further complications reported.
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Event Description
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It was reported that, during npwt, the renasys go failed to charge.The charging connection port seemed burned.Treatment was resumed, with a greater 30 minutes delay, with a back-up device.No patient harm or further complications reported.
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Manufacturer Narrative
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The device was returned for evaluation, confirming the failure to charge event.There was no signs of overheating or burnt components, the overheating event is not confirmed.Visual inspection noted wear and tear defects to the outer casing, confirming that the dc inlet port was broken.The functional evaluation confirmed that the device could not be charged as a causal effect of the broken dc inlet port.The probable root cause is deemed to be wear from use.A documentation review has been conducted, confirming previous complaints of this nature, no manufacturing problems or historical escalations were observed.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.This investigation is now complete, with no manufacturing problems observed, no corrective actions are deemed necessary.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.
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Search Alerts/Recalls
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