On 20th of april 2021 getinge became aware of an issue with one of our surgical light ¿ lucea 100.As it was stated during service visit at customer site rust on main arm of device was noticed.No information about any injury was provided, however we decided to report this case in abundance of caution as rust leads to discontinuity of the paint layer and may cause particles falling into sterile field might led to contamination.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The issue was consulted with subject matter expert from manufacturing site and the conclusion was that rust can occur on the parts of the device, which are not covered by paint.At the location where the paint is not present anymore, there is no more protection leading to rust.Therefore the root cause of the rust presence is related to paint chipping.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow detecting the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior of this nature, we shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of d4 model # and catalog # deem required.This is based on internal evaluation.Corrected: model # ard568603999.Catalog # ard568603999.Previous: model # ardlca219001c.Catalog # ardlca219001c.
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