A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.
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It was reported that the device had error code 571.6241.There was patient involvement but no harm.Bd has learned additional information.It was reported that masimo disposables are being used with the etco2 modules at the facility.Received a copy of the customer's medwatch report from fda which states, ¿the six alaris etco2 devices that were sent out (three devices returned, waiting on the other three).All six devices had the same verbiage for the problem and repair.Please see below.Error codes 571.6241 is confirmed due to ferrite cable backed off from power supply connector.Reconnected cable from oridion pcb to j3 of power pcb.Performed preventative maintenance with the passed result.The six serial numbers of the down etco2 modules are (b)(6).These devices are four months old, placed in service in june 2023.Six failures of our thirty devices is a 20% failure rate.".
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Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Correction : date of event, describe event or problem, fda notified?, report source other.Additional information : report source, device eval by manufacturer?, reason code for no evaluation, if other specify, imdrf annex a, g, b, c, d codes and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.H3 other text : not applicable.Device evaluated by bd.
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