Medtronic received information that prior to use of a bio-console 560 controller instrument, it was reported that the unit will not stay powered on when removed from ac power.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Biomed wanted information regarding battery indicator dropping when ac power is restored to unit.Service technician emailed documentation to biomed.Medtronic received additional information that the battery was installed on the 22 aug 2019.The lot number of the removed battery is 10069378.
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Device evaluation summary: the reported issue that the instrument would not stay powered on when removed from ac power was verified during service.The field service technician checked the batteries and they were below the minimal voltage.The keypad on the base unit was also malfunctioning and had to be replaced.The issues were resolved by replacing the battery,12v,6.5 ah,certified and the keypad membrane 560 bioconsole.After repairs, the instrument passed all function tests.Preventive maintenance was performed per specifications.Note: the instrument was serviced in the facility by a field service technician.The instrument was not returned to a medtronic facility for service/analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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