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The biomedical engineer reported that they are having an error populate on the multigas unit stating a "device error." it is intermittent, and it disappears once they reboot it.However, one of the doctors has complained that a very loud screeching noise comes from the unit almost as if a screw is loose inside.They called back when they attempted to do an operational check on the unit, the gas monitor did not power on.Tech support (ts) informed them that in order for the gas bench to turn on, it must sense a connection with a bedside monitor (bsm) via the interface (if) cable.They stated that they would have to locate a connection if cable, and connect the gas bench to a bsm.No patient harm was reported.
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Details of the complaint: the biomedical engineer reported that they are having an error populate on the multigas unit stating a "device error." it is intermittent, and it disappears once they reboot it.However, one of the doctors has complained that a very loud screeching noise comes from the unit almost as if a screw is loose inside.They called back when they attempted to do an operational check on the unit, the gas monitor did not power on.No patient harm was reported.Service requested / performed: sensor was replaced.Investigation conclusion: the root cause is determined to be component failure: sensor needed replacement.Sensor is a replaceable component, where the longevity is dependent upon the following factors: instrument and parts must undergo regular maintenance inspection at least every 6 months.If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.Water trap should be replaced every 4 weeks or as indicated on the device.Ensuring the environment is optimal as described in the operator's manual.When the issue is not duplicated during evaluation, the possible causes are related to the appropriate connection of the air tubes, connectors, and watertrap.The root cause of the reported issue is attributable to the state of wear-components such as watertrap, connectors, sampling line, and/or device damage.The following fields are not applicable (na) to the mdr report: b2 d4 lot number & expiration d6a - d6b d7b f1 - f14 g4 device bla number g5 g7 h7 h9 the following fields contains no information (ni), as attempts to obtain information were made, but not provided.A2 - a6 b6 - b7 attempt #1 12/09/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 12/20/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 12/21/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the patient information as requested.Additional device information: d10: concomitant medical device: the following device(s) were being used in conjunction with the multigas unit, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Attempt #1 12/09/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 12/20/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 12/21/2021 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.Bedside monitor model: ni.Sn: ni.Additional information: b4 date of this report.D9 device available for evaluation.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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The biomedical engineer reported that they are having an error populate on the multigas unit stating a "device error." it is intermittent, and it disappears once they reboot it.However, one of the doctors has complained that a very loud screeching noise comes from the unit almost as if a screw is loose inside.They called back when they attempted to do an operational check on the unit, the gas monitor did not power on.Tech support (ts) informed them that in order for the gas bench to turn on, it must sense a connection with a bedside monitor (bsm) via the interface (if) cable.They stated that they would have to locate a connection if cable, and connect the gas bench to a bsm.No patient harm was reported.
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