Manufacturer's investigation conclusion: the reported event of the centrimag battery being expired out of box was confirmed, as the returned centrimag battery (serial number (b)(6)) was observed to have expired on 30nov2020 upon arrival.The returned battery was connected within a known working test centrimag console and was tested alongside known working test centrimag equipment.When ac power was disconnected from the console, the battery operated the system as intended for an extended period despite the battery having been expired.Battery maintenance was also performed with the returned battery, and the battery passed.Atypical events were unable to be reproduced throughout all testing.A corrective action is being requested in order to address the issue of the battery being expired out of box.Review of the device history record for centrimag battery, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.Review of the device history record for centrimag console that the battery was placed in (serial number (b)(6)) also showed device was manufactured in accordance with manufacturing and qa specifications.The centrimag operating manual ¿2nd generation centrimag primary console maintenance schedule¿ instructs users that the centrimag¿s internal battery must be replaced every two years.However, the user may not replace the battery without proper training.Users are instructed to request assistance by contacting abbott if the internal battery requires replacement.No further information was provided.The manufacturer is closing the file on this event.
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Additional information to the manufacturer's investigation conclusion: a manufacturing analysis task was opened in order to further investigate the issue of the battery being expired out-of-box, and the centrimag manufacturing procedure was updated as a result; however, the root cause of the reported event was unable to be conclusively determined.No further information was provided.The manufacturer is closing the file on this event.
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