On 24th march 2022, getinge became aware of an issue with one of the surgical lights - volista standop.As it was stated, paint was chipping from the spring arm.On (b)(6) 2022, the photos with visible rust occurrence and paint chipping on suspension arm, fork and main tube were received.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Initially, the issue was reported under (b)(4) (report#: 9710055-2019-00023) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.
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The correction of b5 describe event or problem deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 19th may, 2022 getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was chipping from the spring arm.On (b)(6) 2022, the photos with visible rust occurrence were received.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event or problem: on 24th march 2022 getinge became aware of an issue with one of the surgical lights - volista standop.As it was stated, paint was chipping from the spring arm.On (b)(6) 2022, the photos with visible rust occurrence and paint chipping on suspension arm, fork and main tube were received.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Initially, the issue was reported under: (b)(4) (report#: 9710055-2019-00023) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.Getinge became aware of an issue with one of the surgical lights - volista standop.It was stated based on the received photos that the paint was chipping from the spring arm, suspension arm, fork and main tube as well as rust was detected on these components.We decided to report the issue in abundance of caution as any particles falling off into a sterile field or during a procedure may cause contamination.Initially, the issue was reported under: (b)(4) and getinge sales and service unit has not received the customer¿s approval to proceed with the repair.Therefore, with this complaint at hand, taking into consideration the customer¿s refusal, it can be assumed that the malfunction initially reported could have progressed overtime and has been claimed again.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since appearance of paint peeling and corrosion could be considered as technical deficiency, and in this way devices contributed to event.It remains unknown whether the affected device was or was not being used for patient treatment or diagnosis when the event occurred.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at a low ratio.As stated by subject matter expert at the manufacturer¿s site, the oxidation has been detected between the fork and the sleeve of spring arm.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.This event is clearly due to the cleaning product.Nevertheless, the deterioration of the paint is far advanced and it must have started years ago.Such troubles should have been detected first by the user during daily and monthly checks.The current cleaning product must be improved as described in the user manual.The damaged parts must be replaced as soon as possible.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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