Additional information added to: e2, g2 for biomed as health professional.This device was evaluated and repaired through the service repair process.Upon visual inspection the service technician noted that failed pm with error code 570.6500 was confirmed due to a bad oridion board, replaced it a new oridion board.Performed leak down test and co2 calibration with passing results.The failure code othe was used to track the alaris pump software version as received from the customer and the software version when device was sent back to the customer.It does not reflect a device failure or represent any risk to the patient.Based on the findings, service determined that the probable root cause of the reported issue was due to electrical failure of the oridion board assembly etco2 v1rohs a review of the device history record showed the device had a manufacture date of 03apr2019.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for sn (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the sn (b)(6) did not confirm similar complaints with the same or related failure mode for this customer.
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