SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568S |
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 12/08/2021 |
Event Type
malfunction
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Event Description
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It was reported that, during set up, the fans of the 'light source, xenon' were not engaging so the unit overheated.There was a backup device available and no delay was reported.There was no patient involvement.
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Manufacturer Narrative
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Internal complaint reference case-(b)(4).
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Manufacturer Narrative
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H3, h6: the reported device was received for evaluation.A visual inspection was performed on the exterior of the device and no deficiencies were observed.A functional evaluation revealed the ballast fan stops after power up.No overheating message was observed.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with component failure.Factors, unrelated to the manufacturing and design of the device that could have contributed to the reported event, include a defective circuit board or other component.When a fan stops there is the potential for the internal temperature of the device to rise.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.No containment or corrective actions are recommended at this time.
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