|
Model Number 560BCS1 |
Device Problems
Device Alarm System (1012); Battery Problem (2885)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2024 |
Event Type
malfunction
|
Event Description
|
Medtronic received information that prior to use of a bio-console 560 instrument, it was reported that the mpu detected that the batteries were open or defective.The use of the instrument was unknown.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was a battery issue and error 69 displayed.
|
|
Manufacturer Narrative
|
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
|
Device evaluation summary: the reported issue that the batteries were open or defective was verified during service.The issue will be resolved by replacing the batteries and calibration, system testing will be performed.Preventative maintenance will be performed per specifications.Medtronic received additional information that the customer has decided not to proceed with the instrument repair.Correction to notified date: is 04 mar 2024.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
|
|
|