The biomedical engineer reported that the multigas unit was giving a "device not found - flashed enabled" error message and stated that the fan was not working on the unit.Gas unit was not reading gas numerical values and the error did not disappear.No patient harm reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Additional model information: concomitant medical device field contains no information (ni), as attempts to obtain information were made, but not provided.
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Details of complaint: customer reported that the fan on the multigas unit had malfunctioned.Additionally, they were getting an "error device not found / flash enabled" message from the device at the connected bedside monitor.Because of this, the device could not give gas measurements.The device was sent in for evaluation and exchange.Service requested / performed: exchange / evaluation: nka's repair center evaluated the device.The device gave a "gas device error" message.An investigation was conducted under irc-nka300155492 and concluded that for gf-210ra, revision cb and onward, with sensor unit cd-314p, revision 2 (serial numbers (b)(6)) needed a firmware upgrade.Revision 2 of cd-314p utilizes a new pump with a slight difference in specification.The sensor unit detects this small difference and output as the "gas device error" message.The countermeasure is to perform a firmware upgrade.The firmware was updated on (b)(6) 2020.The device performed per specifications.Investigation summary: the overall risk score is high.The root cause is determined to be incompatible software with sensor unit cd-314p.The firmware update resolved the issue.Hha-19-010a was conducted to assess health impact.The following fields are not applicable (na) to the mdr report: d4 lot # & expiration date g4 device bla number the following fields contain no information (ni), as attempts to obtain information were made, but not provided: additional information: b4 date of this report 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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