SMITH & NEPHEW, INC. SVCE REPL LIGHT SOURCE 500XL XENON; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
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Catalog Number 72200568S |
Device Problem
Overheating of Device (1437)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/22/2019 |
Event Type
malfunction
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Event Description
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It was reported that the light source was too hot.No case was involved.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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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 an e-12 errors was confirmed.E12 is the error code for overheating.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 mcu pcb.Unit passes functional testing and fans perform as expected with a known good mcu pcb and power supply/ballast installed.The complaint investigation has concluded the cause of the failure to be a defective electronic component on the mcu pcb.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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