On 21st january, 2021 getinge became aware of an issue with prismatic surgical light.As it was stated, both lights turned off during procedure.There was no injury reported.We decided to report the event in abundance of caution as it may cause a delay in life-saving treatment.
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Getinge became aware of an issue with prismatic surgical light.As it was stated, both lights turned off during procedure.There was no injury reported.We decided to report the event in abundance of caution as it may cause a delay in lifesaving treatment.It was established that when the event occurred, the device did not meet its specification as it should not turn off and it contributed to the event.The provided information indicated that the device was being used for patient treatment when the event took place.During the investigation it was found that it is considered as single and isolated event.According to the information collected, it seems that the power supply of that the device was not involved, the power failure came from the hospitals' main power supply.It is not possible to determine the root cause and therefore the factory investigation report cannot be performed.In case of new relevant information, the case will be reconsidered.We believe that remaining devices are performing correctly in the market.
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