The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.The rv coil continuity was indicated to be lower than 200 ohms in the remote report dated of the 11 october 2022.However, the analysis of the provided expertise files confirmed the rv coil continuity measurement stored in the device memory was in fact 325 ohms on (b)(6) 2022.The observed mismatch between the measured value and the displayed value could result from a software anomaly, which occurred under specific conditions, leading to the storage of the programmed amplitude parameter in the device statistics instead of the measured amplitude.Therefore, the calculation of the last rv coil continuity value was made with the wrong amplitude value and the result obtained was therefore wrong, thus explaining why 200 ohms¿ was displayed in the remote report.It should be noted that the rv coil continuity curve displayed the correct impedance value.The correct impedance value on (b)(6) 2022 is 325 ohms (normal range).Corrective actions of this software issue are currently being contemplated.
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