Model Number K10020641 |
Device Problems
Device Emits Odor (1425); Overheating of Device (1437)
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Patient Problems
Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Reported in an abundance of caution.Field service engineer (fse) attended site on 9 december 2020.Waiting for report following site visit to be submitted.Outcome of fse report will determine next steps.
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Event Description
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Customer reported that users could smell faint burning smell and overheating.This occurred and was noticed during procedures.No harm to patient or user.Procedures carried out as normal and no delays.Users did re-locate to another room as a precaution.
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Manufacturer Narrative
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Reference the technical report provided.The device was inspected by a field service engineer.There was no evidence of burning.It was cleaned of dust and left to run for an hour - no smell or fault found.Equipment returned to use.H3 other text: field service engineer attended site.
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Search Alerts/Recalls
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