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Model Number ACT100 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation summary: the reported issue that the electronic and weekly controls appeared functional but displayed discrepancies in patient processing compared to another instrument, was verified during service.The service technician observed that the actrac drop times value was slightly lower, but within specs.Additionally, the sensor board had blood stains, and dust was present on electronic components.The issues were resolved by cleaning the sensor board, removing dust from electronics and replacing the assy switch softkey act plus, the assy switch keypad act pls, the keypad overlay intl act plus and the overlay softkey intl act plus.Preventive maintenance was performed per specifications.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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Event Description
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Medtronic received information that during use of an act plus instrument, it was reported that the electronic and weekly controls are ok but when a patient is processed the customer sees a difference that does not make sense compared to the other machine they have.The customer had a result that seemed to be wrong, so they analyzed in both rooms and the one in the phillips room was 425 and in the siemens room was 248.The use of the instrument was unspecified.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer analyzed the samples on the customers two units, including the reported unit.The blood sheep is referring to the act controls.Cartridge lot# 227359851, normal control lot# 226863754, abnormal control lot# 228064786.Electronic quality control is performed daily, and blood sheep is performed weekly, and no error code was associated with this issue.
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Search Alerts/Recalls
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