|
Model Number ACT200 |
Device Problem
Electrical /Electronic Property Problem (1198)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/19/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Correction h6: updates to 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.
|
|
Event Description
|
Medtronic received information that prior to use of an act plus instrument, it was reported that the unit was giving unreliable reading values.Use of instrument was unspecified.There was no patient involvement, so no adverse effect occurred.
|
|
Manufacturer Narrative
|
Device evaluation summary: the reported unreliable reading issue was verified during service.Service technician observed the reported issue and found the sensor card flag was too dirty.The issue was resolved by cleaning the unit and replacing the sensor assy flag.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 b5: medtronic received additional information that no cartridge was used.Act trac controls were used.The quality control is performed once a year for this unit.There was no error code associated with this issue and no control values were obtained.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
|
|
|