Model Number ILED 5K ALC+ |
Device Problems
Device Maintenance Issue (1379); Device Issue (2379); Facilities Issue (2935); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The use of prohibited cleaning agents with chlorine can damage powder coat surfaces.Corrosion that occurs and over time (months to years) spreads under the coating and lifts up the powder coating.Agitation (wipe down / collision) can cause powder coating to fall off.Product user manuals provide a list of agents which are chemical compatibility tested and approved by trumpf medical for cleaning and disinfecting.
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Event Description
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Trumpf medical was informed by a customer that paint from the surface of a surgical light was chipping with risk of falling off.
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Manufacturer Narrative
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The affected device was replaced at the facility.The returned, defective parts were investigated and evaluated.Our investigation has identified steps in the manufacturing process which combined with non-approved cleaners can lead to the paint chipping.The damage to the painted surfaces usually does not develop suddenly, but develops over time.The instructions for use state that the devices must be checked for proper condition prior to each use.Damaged devices must not be used.If damage to the surface coating is recognized and removed, there is no danger to the patient.The surface coating process will be updated to include additional testing and verification.
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Search Alerts/Recalls
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