Details of complaint: the biomedical engineer (bme) reported that the multigas unit was getting low etco2 readings.No error messages were displayed.No patient harm was reported.Investigation summary: the customer was provided with an exchanged device and sent the reported device in for evaluation.During the evaluation of the multigas unit, nihon kohden repair center (nk rc) was able to duplicate the reported issue of low etco2 readings.To resolve the issue, the gas module of the device was replaced by an upgraded version with improved pump durability.Failure of the gas module unit is commonly associated with a gas device error.The error corresponds to a failure of the sensor unit - cd314p.An investigation conducted under irc-nka300272435 reported that nkc had issued corrective action 2040-ag0031-00 to the manufacturer of the pump to improve performance and reliability.Gf-210ra with (b)(6)and later are equipped with improved pumps.To identify, the revision of gf-210ra is cg or higher and the model number of the gas unit is cd-314p-04 or higher.This is a known issue and is linked to wear and tear of the motor.When the issue is not duplicated during evaluation, the possible causes are related to the appropriate connection of the air tubes, connectors, and water trap.The serial number of the reported device indicates that this unit did not have the improved pump designed when it experienced the error.The root cause is likely related to wear and tear of the pump.Nk will continue to monitor and trend similar complaints.The following fields contains no information (ni), as attempts to obtain the information were made, but not provided.A2 - a6 b6 - b7 attempt #1 01/18/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 01/25/2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested patient information.Additional device information: d10: concomitant medical device: the following device was being used in conjunction with the multigas unit.Bedside monitor (bsm): model: bsm-6501a sn: (b)(6) additional information: b4 date of this report d8 was this device serviced by a third party? g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.
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