Catalog Number 8607000 |
Device Problems
Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still on-going.The results will be provided with a follow-up report.
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Event Description
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It was reported that during use a ventilator failure was posted.The case was cancelled and was rescheduled.No injury reported.
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Manufacturer Narrative
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The investigation was performed based on the error messages which reportedly were posted during the case in question as no error log was available.The reported error message "membrane pressure low" indicates that the device had shut down automatic ventilation during the course of event due to a problem with the auxiliary vacuum pressure.The device needs a vacuum pressure inside the piston to keep the piston diaphragm in place i.E.To avoid wrinkling of the diaphragm during piston movement.If this vacuum pressure drops below a certain threshold necessary for safe operation the device is designed to shut down automatic ventilation to prevent from serious damages to the ventilator unit.The shut-down is accompanied by a corresponding alarm; patient support can be continued in manual ventilation with the built-in breathing bag.The root cause of the low vacuum pressure could not be determined during on-site examination.The motor was replaced as a precautionary measure but is not in context with the reported symptom.Calibrations were performed and a self test was passed successfully.The device was tested and confirmed to be operating per manufacturer¿s specification being ready for clinical use.Dräger finally concludes that the workstation responded as designed upon a sporadic deviation; automatic ventilation was shut down to avoid severe damages and the user was alerted to the shut-down by means of a dedicated alarm.
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Event Description
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It was reported that during use a ventilator failure was posted.The case was cancelled and was rescheduled.No injury reported.
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Manufacturer Narrative
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Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Device not returned to manufacturer.
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Event Description
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It was reported that during use a ventilator failure was posted.The case was cancelled and was rescheduled.No injury reported.
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Search Alerts/Recalls
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