During installation of a sterilizer, a gravity cycle was relabeled as prevacuum and the program parameters were changed accordingly, but the changed parameters were not saved.After shutdown of the system the parameters reverted to the original gravity cycle parameters while maintaining the prevacuum label.Inadvertently the incorrectly labeled cycle was run three times over the following two months before being detected and corrected.
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Company investigation revealed that the service technician did not save the parameters for the changed program, but only the program name.The changed parameters were saved in the ram memory only.After the next shutdown and reboot of the system, the parameters were set back to the previous saved ones.There have been no issues with the outcome of the sterilization cycle that was run three times with incorrect parameters.The indicators that were placed in the sterilizer together with the sterile goods showed only good results.There are no known incidents with patient involvement due to the event.The program settings have been corrected to match the program name, as originally intended.The system was shut down and it was confirmed that the newly set parameters were correctly saved.Currently, the program is running correctly.
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