|
Model Number 560BCS1 |
Device Problem
Device Alarm System (1012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/19/2024 |
Event Type
malfunction
|
Event Description
|
During preventive maintenance by a service technician this bio-console 560 controller instrument had an mpu board which had a hard offset alarm.This was detected during service so there was no patient involvement, so no adverse effect occurred.
|
|
Manufacturer Narrative
|
Device evaluation summary: during preventive maintenance by service technician, it was observed that bio-console 560 had a mpu board issue, with a hard offset alarm.Issue was resolved by replacing the mpu board.Preventive maintenance was performed as per specification.D9: instrument was serviced at the facility by medtronic field service and was not returned to medtronic service center 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.
|
|
Manufacturer Narrative
|
Additional info h6: updated the fdc and fdr codes 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.
|
|
Search Alerts/Recalls
|
|
|