SMITH & NEPHEW, INC. LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Model Number 72200568 |
Device Problems
Power Problem (3010); Unexpected Shutdown (4019)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported that the power supply of the light source broke down.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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H10 h3, h6: the reported device, intended for use in treatment, was received for evaluation.A visual inspection was performed on the exterior of product and no physical damage was observed.There was a relationship found between the returned device and the reported incident.The complaint of ¿broke down¿ was confirmed.The cooling fan for the ballast/power supply shuts down when unit is powered up causing overheating and errors.Power supply was also electrically damaged due to fan malfunction.Fan malfunction is caused by a defective electronic component.The complaint investigation has concluded the cause of the failure to be a defective electronic component.The device has been in service for over 7 years, thus any malfunction presented at this point in time would not be related to the manufacture of the product.A complaint history review concluded this was a repeat issue.
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Search Alerts/Recalls
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