Catalog Number MK06000 |
Device Problems
Gas Output Problem (1266); High impedance (1291); Calibration Problem (2890); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation has just started; results will be provided in a follow-up report.
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Event Description
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It was reported that the device alerted the calibration of flow sensors.Further n2o was added on its own, despite no n2o was used.Ventilation did not work as it should and the blood gas analysis showed co2 above 8.No serious patient injury reported.
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Event Description
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It was reported that the device alerted the calibration of flow sensors.Further n2o was added on its own, despite no n2o was used.Ventilation did not work as it should and the blood gas analysis showed co2 above 8.No serious patient injury reported.
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Manufacturer Narrative
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Based on the investigation results this case is no longer considered to be reportable.The evaluation of the logfile records revealed that the gas dosage of the electronic gas mixer was accurate.An unintentional administration of n2o as reported could not be confirmed.However, there was an incorrect measurement of the n2o channel by the patient gas measurement module.It was found that the resistor on the pcb of the anesthetic agent sensor became high-impedance being root cause for the identified incorrect measurement.The inspiratory and expiratory gas concentrations are measured permanently.Since the gas readings are not used for control purpose there is no influence on gas dosage or ventilation.A n2o concentration above 82% will be alarmed immediately with an ¿insp.N2o high¿ alarm.Depending on the set alarm limits adjusted by the user additionally an insp.O2 low will be given.Oxygen dosage via the o2 flush as well as the o2 emergency delivery remains possible.
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Search Alerts/Recalls
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