Catalog Number 8603800 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the device failed during use accompanied by a gas mixer failure alarm.Bagged patient and swapped out the unit.No patient consequences have been reported.
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Manufacturer Narrative
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The investigation was just started.The results will be forwarded in a follow-up report.
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Manufacturer Narrative
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The log file analysis revealed that during the case in question the device detected an internal communication error onboard a pcb that controls the communication between user interface, gas mixer and ventilator.The workstation initiated an emergency shutdown of automatic ventilation and posted corresponding alarms.Monitoring and manual ventilation remains possible in this state.The general issue is known from earlier occurrences of the same phenomenon.Intensive evaluation of the provided information and testing of concerned materials did not result in any finding.The fact that the involved pcb is used in another functional unit of the entire device without showing similar symptoms makes a design problem rather unlikely.A reasonable explanation would be emc disturbances beyond the immunity barriers of the workstation which is compliant to iec 60601-1-2.Therefore it is recommended that the conditions at the user facility should be checked to prevent from emc disturbance.The field failure rate of the affected pcb is accepted.
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Event Description
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It was reported that the device failed during use accompanied by a gas mixer failure alarm.Bagged patient and swapped out the unit.No patient consequences have been reported.
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Search Alerts/Recalls
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